{
 "reviewed_on": "2026-10-21",
 "records": [
  {
   "id": "k091588-ucp-home",
   "title": "UCP Home Drug Screening Test Cards and Cup",
   "kind": "fda_device",
   "manufacturer": "UCP Biosciences, Inc.",
   "model": "UCP Home Drug Screening Test Cards; UCP Home Drug Screening Test Cup (card holds up to 10 strips, cup up to 5)",
   "regulatory_number": "K091588",
   "intended_use": "otc",
   "intended_use_label": "Over the counter (home use) and health care professional use",
   "matrix": "urine",
   "panels": null,
   "analytes": [
    "AMP",
    "BAR",
    "BZO",
    "COC",
    "MTD",
    "MET",
    "MDMA",
    "MOP",
    "OPI",
    "OXY",
    "PCP",
    "TCA",
    "THC"
   ],
   "fda_record": true,
   "independent": false,
   "tier": "B",
   "reviewed": "2026-10-21",
   "page": "/test-kit-guide/k091588-ucp-home/",
   "limitations": "Sponsor-run lay-user study with spiked urine, cleared in 2009; agreement is lower near the cutoff and figures do not transfer to other brands, later lots or white-label products.",
   "sources": [
    {
     "label": "FDA 510(k) decision summary K091588",
     "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf",
     "publisher": "U.S. Food and Drug Administration",
     "verified": "2026-10-21"
    },
    {
     "label": "FDA 510(k) database record K091588",
     "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091588",
     "publisher": "U.S. Food and Drug Administration",
     "verified": "2026-10-21"
    }
   ],
   "metrics": [
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 1000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"AMP\")",
     "value_percent": 99.1,
     "denominator": "226/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 94.4 / 94.4 / 100 / 100%. Near cutoff: 75% = 17/18 read negative, 125% = 17/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=6",
     "source_page": "PDF page 6, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "BAR",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"BAR\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 88.9 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=6",
     "source_page": "PDF page 6, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "BZO",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"BENZO\")",
     "value_percent": 98.2,
     "denominator": "225/229 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 100 / 77.8 / 100 / 100%. Near cutoff: 75% = 18/18 read negative, 125% = 14/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. The table states 98.2%; its own counts give 98.3%."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"COC\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 83.3 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "MTD",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"Methadone\")",
     "value_percent": 99.1,
     "denominator": "226/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 94.7 / 94.4 / 100 / 100%. Near cutoff: 75% = 17/18 read negative, 125% = 17/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. At 75% of cutoff the table prints 94.7%; its counts (17 of 18) give 94.4%."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 1000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"Methamp\")",
     "value_percent": 98.2,
     "denominator": "224/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 88.9 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "MDMA",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"MDMA\")",
     "value_percent": 96.9,
     "denominator": "221/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 77.8 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 14/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "MOP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"Morphine\")",
     "value_percent": 97.4,
     "denominator": "222/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 83.3 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "OXY",
     "cutoff_ng_ml": 100,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"Oxycod.\")",
     "value_percent": 97.4,
     "denominator": "222/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 77.8 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 14/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "OPI",
     "cutoff_ng_ml": 2000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"Opiates (Morphine)\")",
     "value_percent": 97.4,
     "denominator": "224/230 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 83.3 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "PCP",
     "cutoff_ng_ml": 25,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"PCP\")",
     "value_percent": 98.7,
     "denominator": "225/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 94.4 / 88.9 / 100 / 100%. Near cutoff: 75% = 17/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "TCA",
     "cutoff_ng_ml": 1000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"TCA\")",
     "value_percent": 98.2,
     "denominator": "224/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 88.9 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "HPLC (TCA samples)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "THC",
     "cutoff_ng_ml": 50,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_card",
     "study_type_label": "Lay-user study, spiked urine, test card",
     "metric_label": "Observed total percent agreement (test card, row \"THC\")",
     "value_percent": 98.2,
     "denominator": "226/230 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 88.9 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=7",
     "source_page": "PDF page 7, table \"UCP Home Drug Screening Test Card\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. The table states 98.2%; its own counts give 98.3%."
    },
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 1000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"AMP\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 88.9 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "BAR",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"BAR\")",
     "value_percent": 96.9,
     "denominator": "221/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 77.8 / 83.3 / 100 / 100%. Near cutoff: 75% = 14/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "BZO",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"BENZO\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 94.4 / 77.8 / 100 / 100%. Near cutoff: 75% = 17/18 read negative, 125% = 14/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"COC\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 83.3 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "MTD",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"Methadone\")",
     "value_percent": 98.2,
     "denominator": "224/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 88.9 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 16/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 1000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"Methamp\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.8 / 83.3 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. At 75% of cutoff the table prints 88.8%; its counts (16 of 18) give 88.9%."
    },
    {
     "analyte": "MDMA",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"MDMA\")",
     "value_percent": 97.4,
     "denominator": "222/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.2 / 83.3 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. At 75% of cutoff the table prints 83.2%; its counts (15 of 18) give 83.3%."
    },
    {
     "analyte": "MOP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"Morphine\")",
     "value_percent": 97.4,
     "denominator": "222/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.2 / 83.3 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. At 75% of cutoff the table prints 83.2%; its counts (15 of 18) give 83.3%."
    },
    {
     "analyte": "OXY",
     "cutoff_ng_ml": 100,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"Oxycod.\")",
     "value_percent": 97.8,
     "denominator": "223/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 88.9 / 83.3 / 100 / 100%. Near cutoff: 75% = 16/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF page 8, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "OPI",
     "cutoff_ng_ml": 2000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"Opiates (Morphine)\")",
     "value_percent": 97.4,
     "denominator": "224/230 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 83.3 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=8",
     "source_page": "PDF pages 8-9, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "PCP",
     "cutoff_ng_ml": 25,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"PCP\")",
     "value_percent": 97.4,
     "denominator": "222/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 84.2 / 83.3 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=9",
     "source_page": "PDF page 9, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product. At 75% of cutoff the table prints 84.2%; its counts (15 of 18) give 83.3%."
    },
    {
     "analyte": "TCA",
     "cutoff_ng_ml": 1000,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"TCA\")",
     "value_percent": 96.9,
     "denominator": "221/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 77.8 / 83.3 / 100 / 100%. Near cutoff: 75% = 14/18 read negative, 125% = 15/18 read positive.",
     "reference_method": "HPLC (TCA samples)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=9",
     "source_page": "PDF page 9, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    },
    {
     "analyte": "THC",
     "cutoff_ng_ml": 50,
     "matrix": "urine",
     "study_type": "lay_user_spiked_urine_cup",
     "study_type_label": "Lay-user study, spiked urine, test cup",
     "metric_label": "Observed total percent agreement (test cup, row \"THC\")",
     "value_percent": 96.9,
     "denominator": "221/228 readings (summed from the table's per-concentration counts)",
     "near_cutoff": "Agreement at 0% / 50% / 75% / 125% / 150% / 300% of cutoff: 100 / 100 / 83.3 / 77.8 / 100 / 100%. Near cutoff: 75% = 15/18 read negative, 125% = 14/18 read positive.",
     "reference_method": "GC/MS (spiked concentrations verified)",
     "sponsor": "Sponsor (UCP Biosciences) study, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf#page=9",
     "source_page": "PDF page 9, table \"UCP Home Drug Screening Test Cups\"",
     "tier": "B",
     "context": "Share of lay-user readings that matched the expected result for drug-free and spiked urine samples in this one sponsor study. It is not clinical sensitivity or specificity, not a real-world accuracy rate and not a claim about any other product."
    }
   ],
   "card": {
    "group": "home",
    "tags": [
     "FDA record",
     "Home use"
    ],
    "evidence": "FDA review of sponsor study data (tier B)",
    "analytes": "13 drugs and drug classes",
    "cutoff": "AMP 1,000 ng/mL; THC 50 ng/mL; PCP 25 ng/mL (13 cutoffs listed)",
    "source": 0,
    "ref": "FDA K091588",
    "use_short": "Over the counter (home) and professional use"
   }
  },
  {
   "id": "k091612-ucp-rapid-rx",
   "title": "UCP Rapid Drug Screening BUP, AMP 300, mAMP 500 and Cocaine 150 Tests",
   "kind": "fda_device",
   "manufacturer": "UCP Biosciences, Inc.",
   "model": "UCP Rapid Drug Screening BUP, AMP 300, mAMP 500 and Cocaine 150 Tests (dip card, cassette and cup formats)",
   "regulatory_number": "K091612",
   "intended_use": "rx-poc",
   "intended_use_label": "Prescription use in point-of-care settings (not a consumer retail kit)",
   "matrix": "urine",
   "panels": null,
   "analytes": [
    "AMP",
    "BUP",
    "COC",
    "MET"
   ],
   "fda_record": true,
   "independent": false,
   "tier": "B",
   "reviewed": "2026-10-21",
   "page": "/test-kit-guide/k091612-ucp-rapid-rx/",
   "limitations": "Prescription point-of-care device, not cleared for home use; sponsor studies with 30 determinations per concentration and 80 clinical samples per drug per format.",
   "sources": [
    {
     "label": "FDA 510(k) decision summary K091612",
     "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf",
     "publisher": "U.S. Food and Drug Administration",
     "verified": "2026-10-21"
    },
    {
     "label": "FDA 510(k) database record K091612",
     "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091612",
     "publisher": "U.S. Food and Drug Administration",
     "verified": "2026-10-21"
    }
   ],
   "metrics": [
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_dipcard",
     "study_type_label": "Point-of-care reproducibility, spiked urine, dip card",
     "metric_label": "Results by concentration (dip card)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (225 ng/mL): 20 negative / 10 positive of 30; 125% of cutoff (375 ng/mL): 11 negative / 19 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Amphetamine cutoff 300 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cassette",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cassette",
     "metric_label": "Results by concentration (cassette)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (225 ng/mL): 19 negative / 11 positive of 30; 125% of cutoff (375 ng/mL): 12 negative / 18 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Amphetamine cutoff 300 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cup",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cup",
     "metric_label": "Results by concentration (cup)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (225 ng/mL): 18 negative / 12 positive of 30; 125% of cutoff (375 ng/mL): 13 negative / 17 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Amphetamine cutoff 300 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_dipcard",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, dip card",
     "metric_label": "Device result vs mass spectrometry (dip card)",
     "value_percent": null,
     "denominator": "80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 8 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 6 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=9",
     "source_page": "PDF page 9, table \"Test Card\", row \"AMP (300)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cassette",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cassette",
     "metric_label": "Device result vs mass spectrometry (cassette)",
     "value_percent": null,
     "denominator": "80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 8 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 6 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cassette\", row \"AMP (300)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "AMP",
     "cutoff_ng_ml": 300,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cup",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cup",
     "metric_label": "Device result vs mass spectrometry (cup)",
     "value_percent": null,
     "denominator": "80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 8 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 6 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cup\", row \"AMP (300)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_dipcard",
     "study_type_label": "Point-of-care reproducibility, spiked urine, dip card",
     "metric_label": "Results by concentration (dip card)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (375 ng/mL): 18 negative / 12 positive of 30; 125% of cutoff (625 ng/mL): 11 negative / 19 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Methamphetamine cutoff 500 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cassette",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cassette",
     "metric_label": "Results by concentration (cassette)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (375 ng/mL): 19 negative / 11 positive of 30; 125% of cutoff (625 ng/mL): 13 negative / 17 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Methamphetamine cutoff 500 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cup",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cup",
     "metric_label": "Results by concentration (cup)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (375 ng/mL): 18 negative / 12 positive of 30; 125% of cutoff (625 ng/mL): 11 negative / 19 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Methamphetamine cutoff 500 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_dipcard",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, dip card",
     "metric_label": "Device result vs mass spectrometry (dip card)",
     "value_percent": null,
     "denominator": "80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 7 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 8 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=9",
     "source_page": "PDF page 9, table \"Test Card\", row \"mAMP (500)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cassette",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cassette",
     "metric_label": "Device result vs mass spectrometry (cassette)",
     "value_percent": null,
     "denominator": "80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 7 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 8 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cassette\", row \"mAMP (500)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "MET",
     "cutoff_ng_ml": 500,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cup",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cup",
     "metric_label": "Device result vs mass spectrometry (cup)",
     "value_percent": null,
     "denominator": "80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 7 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 8 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cup\", row \"mAMP (500)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 150,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_dipcard",
     "study_type_label": "Point-of-care reproducibility, spiked urine, dip card",
     "metric_label": "Results by concentration (dip card)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (112.5 ng/mL): 20 negative / 10 positive of 30; 125% of cutoff (187.5 ng/mL): 9 negative / 21 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Cocaine cutoff 150 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 150,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cassette",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cassette",
     "metric_label": "Results by concentration (cassette)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (112.5 ng/mL): 19 negative / 11 positive of 30; 125% of cutoff (187.5 ng/mL): 12 negative / 18 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Cocaine cutoff 150 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 150,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cup",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cup",
     "metric_label": "Results by concentration (cup)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (112.5 ng/mL): 19 negative / 11 positive of 30; 125% of cutoff (187.5 ng/mL): 12 negative / 18 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=5",
     "source_page": "PDF page 5, table \"Cocaine cutoff 150 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 150,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_dipcard",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, dip card",
     "metric_label": "Device result vs mass spectrometry (dip card)",
     "value_percent": null,
     "denominator": "80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 7 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 8 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=9",
     "source_page": "PDF page 9, table \"Test Card\", row \"COC (150)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 150,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cassette",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cassette",
     "metric_label": "Device result vs mass spectrometry (cassette)",
     "value_percent": null,
     "denominator": "80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 7 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 8 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cassette\", row \"COC (150)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "COC",
     "cutoff_ng_ml": 150,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cup",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cup",
     "metric_label": "Device result vs mass spectrometry (cup)",
     "value_percent": null,
     "denominator": "80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 7 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 8 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cup\", row \"COC (150)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "BUP",
     "cutoff_ng_ml": 10,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_dipcard",
     "study_type_label": "Point-of-care reproducibility, spiked urine, dip card",
     "metric_label": "Results by concentration (dip card)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (7.5 ng/mL): 20 negative / 10 positive of 30; 125% of cutoff (12.5 ng/mL): 11 negative / 19 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=6",
     "source_page": "PDF page 6, table \"Buprenorphine cutoff 10 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed. The 7.5 ng/mL row is labelled \"25%\" in the table; 7.5 ng/mL is 75% of the 10 ng/mL cutoff."
    },
    {
     "analyte": "BUP",
     "cutoff_ng_ml": 10,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cassette",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cassette",
     "metric_label": "Results by concentration (cassette)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (7.5 ng/mL): 19 negative / 11 positive of 30; 125% of cutoff (12.5 ng/mL): 13 negative / 17 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=6",
     "source_page": "PDF page 6, table \"Buprenorphine cutoff 10 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed. The 7.5 ng/mL row is labelled \"25%\" in the table; 7.5 ng/mL is 75% of the 10 ng/mL cutoff."
    },
    {
     "analyte": "BUP",
     "cutoff_ng_ml": 10,
     "matrix": "urine",
     "study_type": "poc_reproducibility_spiked_cup",
     "study_type_label": "Point-of-care reproducibility, spiked urine, cup",
     "metric_label": "Results by concentration (cup)",
     "value_percent": null,
     "denominator": "30 determinations at each concentration for this format",
     "near_cutoff": "75% of cutoff (7.5 ng/mL): 18 negative / 12 positive of 30; 125% of cutoff (12.5 ng/mL): 11 negative / 19 positive of 30; 0% and 50%: 30/30 negative; 150% and 200%: 30/30 positive.",
     "reference_method": "Spiked drug-free urine at stated concentrations (no confirmation method stated for this table)",
     "sponsor": "Sponsor (UCP Biosciences) study at three point-of-care sites, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=6",
     "source_page": "PDF page 6, table \"Buprenorphine cutoff 10 ng/mL\"",
     "tier": "B",
     "context": "Shows how often readings flipped near the cutoff in a prescription point-of-care study. No percentage is stated in the source; counts are shown as printed. The 7.5 ng/mL row is labelled \"25%\" in the table; 7.5 ng/mL is 75% of the 10 ng/mL cutoff."
    },
    {
     "analyte": "BUP",
     "cutoff_ng_ml": 10,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_dipcard",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, dip card",
     "metric_label": "Device result vs mass spectrometry (dip card)",
     "value_percent": null,
     "denominator": "80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 8 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 6 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=9",
     "source_page": "PDF page 9, table \"Test Card\", row \"BUP (10)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "BUP",
     "cutoff_ng_ml": 10,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cassette",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cassette",
     "metric_label": "Device result vs mass spectrometry (cassette)",
     "value_percent": null,
     "denominator": "80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 8 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 6 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cassette\", row \"BUP (10)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    },
    {
     "analyte": "BUP",
     "cutoff_ng_ml": 10,
     "matrix": "urine",
     "study_type": "poc_method_comparison_clinical_ms_cup",
     "study_type_label": "Method comparison, unaltered clinical urine vs GC/MS or LC/MS/MS, cup",
     "metric_label": "Device result vs mass spectrometry (cup)",
     "value_percent": null,
     "denominator": "80 samples: 39 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative",
     "near_cutoff": "Near-cutoff negative (50% below cutoff up to cutoff): 8 of 8 read negative; near-cutoff positive (cutoff up to 50% above): 7 of 8 read positive.",
     "reference_method": "GC/MS or LC/MS/MS",
     "sponsor": "Sponsor (UCP Biosciences) study, one point-of-care site, reviewed by FDA",
     "source_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K091612.pdf#page=10",
     "source_page": "PDF page 10, table \"Test Cup\", row \"BUP (10)\"",
     "tier": "B",
     "context": "Counts as printed; the source states no percentages. One operator per format. Prescription point-of-care device, not a consumer home kit."
    }
   ],
   "card": {
    "group": "professional",
    "tags": [
     "FDA record",
     "Professional only"
    ],
    "evidence": "FDA review of sponsor study data (tier B)",
    "analytes": "BUP, AMP, mAMP (MET), COC",
    "cutoff": "BUP 10, AMP 300, mAMP 500, COC 150 ng/mL",
    "source": 0,
    "ref": "FDA K091612",
    "use_short": "Prescription, point of care; not a home kit"
   }
  },
  {
   "id": "k221871-healstone-accurate-cup",
   "title": "Healstone Accurate Drug of Abuse Urine Test Cup",
   "kind": "fda_device",
   "manufacturer": "Healstone Biotech, Inc.",
   "model": "Healstone Accurate Drug of Abuse Urine Test Cup (OTC) and Healstone Accurate Drug of Abuse Urine Test Cup Rx",
   "regulatory_number": "K221871",
   "intended_use": "otc",
   "intended_use_label": "Over the counter (home use); a separate Rx version is covered by the same clearance",
   "matrix": "urine",
   "panels": null,
   "analytes": [
    "AMP",
    "BUP",
    "BAR",
    "BZO",
    "COC",
    "EDDP",
    "MET",
    "MDMA",
    "OPI",
    "MOP",
    "MTD",
    "OXY",
    "PCP",
    "PPX",
    "TCA",
    "THC"
   ],
   "fda_record": true,
   "independent": false,
   "tier": "Unverified",
   "reviewed": "2026-10-21",
   "page": "/test-kit-guide/k221871-healstone-accurate-cup/",
   "limitations": "Clearance verified, but the FDA decision summary is a one-page triage memo with no performance data; figures in the applicant's own 510(k) summary have not been extracted or verified by us.",
   "sources": [
    {
     "label": "FDA 510(k) database record K221871",
     "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221871",
     "publisher": "U.S. Food and Drug Administration",
     "verified": "2026-10-21"
    },
    {
     "label": "FDA decision summary K221871 (Triage-Quick Review)",
     "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/K221871.pdf",
     "publisher": "U.S. Food and Drug Administration",
     "verified": "2026-10-21"
    },
    {
     "label": "Applicant's 510(k) summary and FDA letter, K221871",
     "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221871.pdf",
     "publisher": "U.S. Food and Drug Administration (applicant document)",
     "verified": "2026-10-21"
    }
   ],
   "metrics": [],
   "card": {
    "group": "home",
    "tags": [
     "FDA record",
     "Home use"
    ],
    "evidence": "FDA clearance verified; performance not verified",
    "analytes": "16 drugs and drug classes",
    "cutoff": "AMP 1,000 or 500 ng/mL; THC 50 ng/mL (per the applicant's indications for use)",
    "source": 0,
    "ref": "FDA K221871",
    "use_short": "Over the counter (home); an Rx version is covered too"
   }
  },
  {
   "id": "jalm-2022-three-poc-devices",
   "title": "Comparative analyses of three point-of-care urine drug test devices (J Appl Lab Med, 2022)",
   "kind": "independent_study",
   "manufacturer": "Waggoner DC, Delaney SR, Korpi-Steiner NL; The Journal of Applied Laboratory Medicine",
   "model": "Profile-V MEDTOX Scan drugs of abuse test; Quidel Triage TOX Drug Screen; Quidel Triage Rapid OXY-BUP-MDMA panel",
   "regulatory_number": null,
   "intended_use": "rx-poc",
   "intended_use_label": "Professional point-of-care devices in ambulatory clinics (independent study)",
   "matrix": "urine",
   "panels": null,
   "analytes": [
    "ALL"
   ],
   "fda_record": false,
   "independent": true,
   "tier": "A",
   "reviewed": "2026-10-21",
   "page": "/test-kit-guide/jalm-2022-three-poc-devices/",
   "limitations": "Three professional point-of-care devices, 106 residual clinical specimens; we use only the abstract's pooled figures. Not evidence about any home kit.",
   "sources": [
    {
     "label": "Article page (full text for subscribers)",
     "url": "https://academic.oup.com/jalm/article/7/2/495/6379040",
     "publisher": "The Journal of Applied Laboratory Medicine / Oxford University Press",
     "verified": "2026-10-21"
    },
    {
     "label": "PubMed abstract, PMID 34597363",
     "url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "publisher": "U.S. National Library of Medicine",
     "verified": "2026-10-21"
    }
   ],
   "metrics": [
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_clinical_residual_urine_vs_ms_pooled",
     "study_type_label": "Independent study, residual clinical urine vs mass spectrometry, pooled across drug classes",
     "metric_label": "Overall sensitivity, Profile-V MEDTOX Scan drugs of abuse test (manufacturer-stated cutoffs)",
     "value_percent": 98.6,
     "denominator": "Not stated per device in the abstract (106 specimens in total; 84/106 positive for one or more drugs by mass spectrometry)",
     "near_cutoff": null,
     "reference_method": "Quantitative mass spectrometry",
     "sponsor": "Independent academic authors; funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "source_page": "Abstract, Results (PubMed 34597363)",
     "tier": "A",
     "context": "Pooled across drug classes for this one evaluated professional point-of-care device; the abstract says performance varied across drug classes. Not evidence about any home kit."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_clinical_residual_urine_vs_ms_pooled",
     "study_type_label": "Independent study, residual clinical urine vs mass spectrometry, pooled across drug classes",
     "metric_label": "Overall specificity, Profile-V MEDTOX Scan drugs of abuse test (manufacturer-stated cutoffs)",
     "value_percent": 90.1,
     "denominator": "Not stated per device in the abstract (106 specimens in total; 84/106 positive for one or more drugs by mass spectrometry)",
     "near_cutoff": null,
     "reference_method": "Quantitative mass spectrometry",
     "sponsor": "Independent academic authors; funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "source_page": "Abstract, Results (PubMed 34597363)",
     "tier": "A",
     "context": "Pooled across drug classes for this one evaluated professional point-of-care device; the abstract says performance varied across drug classes. Not evidence about any home kit."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_clinical_residual_urine_vs_ms_pooled",
     "study_type_label": "Independent study, residual clinical urine vs mass spectrometry, pooled across drug classes",
     "metric_label": "Overall sensitivity, Quidel Triage TOX Drug Screen (manufacturer-stated cutoffs)",
     "value_percent": 97.0,
     "denominator": "Not stated per device in the abstract (106 specimens in total; 84/106 positive for one or more drugs by mass spectrometry)",
     "near_cutoff": null,
     "reference_method": "Quantitative mass spectrometry",
     "sponsor": "Independent academic authors; funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "source_page": "Abstract, Results (PubMed 34597363)",
     "tier": "A",
     "context": "Pooled across drug classes for this one evaluated professional point-of-care device; the abstract says performance varied across drug classes. Not evidence about any home kit."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_clinical_residual_urine_vs_ms_pooled",
     "study_type_label": "Independent study, residual clinical urine vs mass spectrometry, pooled across drug classes",
     "metric_label": "Overall specificity, Quidel Triage TOX Drug Screen (manufacturer-stated cutoffs)",
     "value_percent": 89.0,
     "denominator": "Not stated per device in the abstract (106 specimens in total; 84/106 positive for one or more drugs by mass spectrometry)",
     "near_cutoff": null,
     "reference_method": "Quantitative mass spectrometry",
     "sponsor": "Independent academic authors; funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "source_page": "Abstract, Results (PubMed 34597363)",
     "tier": "A",
     "context": "Pooled across drug classes for this one evaluated professional point-of-care device; the abstract says performance varied across drug classes. Not evidence about any home kit."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_clinical_residual_urine_vs_ms_pooled",
     "study_type_label": "Independent study, residual clinical urine vs mass spectrometry, pooled across drug classes",
     "metric_label": "Overall sensitivity, Quidel Triage Rapid OXY-BUP-MDMA panel (manufacturer-stated cutoffs)",
     "value_percent": 100.0,
     "denominator": "Not stated per device in the abstract (106 specimens in total; 84/106 positive for one or more drugs by mass spectrometry)",
     "near_cutoff": null,
     "reference_method": "Quantitative mass spectrometry",
     "sponsor": "Independent academic authors; funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "source_page": "Abstract, Results (PubMed 34597363)",
     "tier": "A",
     "context": "Pooled across drug classes for this one evaluated professional point-of-care device; the abstract says performance varied across drug classes. Not evidence about any home kit."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_clinical_residual_urine_vs_ms_pooled",
     "study_type_label": "Independent study, residual clinical urine vs mass spectrometry, pooled across drug classes",
     "metric_label": "Overall specificity, Quidel Triage Rapid OXY-BUP-MDMA panel (manufacturer-stated cutoffs)",
     "value_percent": 50.0,
     "denominator": "Not stated per device in the abstract (106 specimens in total; 84/106 positive for one or more drugs by mass spectrometry)",
     "near_cutoff": null,
     "reference_method": "Quantitative mass spectrometry",
     "sponsor": "Independent academic authors; funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/34597363/",
     "source_page": "Abstract, Results (PubMed 34597363)",
     "tier": "A",
     "context": "Pooled across drug classes for this one evaluated professional point-of-care device; the abstract says performance varied across drug classes. Not evidence about any home kit."
    }
   ],
   "card": {
    "group": "research",
    "tags": [
     "Independent study",
     "Not a home kit"
    ],
    "evidence": "Independent peer-reviewed study (tier A for the three devices only)",
    "analytes": "Pooled across drug classes",
    "cutoff": "Manufacturer-stated cutoffs (not listed in the abstract)",
    "source": 1,
    "ref": "J Appl Lab Med · 2022 · PMID 34597363",
    "use_short": "Professional point-of-care devices in clinics"
   }
  },
  {
   "id": "beck-2014-on-site-urine-testing",
   "title": "Laboratory and clinical evaluation of on-site urine drug testing (Scand J Clin Lab Invest, 2014)",
   "kind": "independent_study",
   "manufacturer": "Beck O, Carlsson S, Tusic M, Olsson R, Franzen L, Hulten P; Scandinavian Journal of Clinical and Laboratory Investigation",
   "model": "On-site urine drug testing product (not named in the abstract)",
   "regulatory_number": null,
   "intended_use": "rx-poc",
   "intended_use_label": "On-site testing in a laboratory and a dependency clinic (independent study)",
   "matrix": "urine",
   "panels": null,
   "analytes": [
    "ALL"
   ],
   "fda_record": false,
   "independent": true,
   "tier": "Unverified",
   "reviewed": "2026-10-21",
   "page": "/test-kit-guide/beck-2014-on-site-urine-testing/",
   "limitations": "The accessible abstract does not name the product or give sample counts, so its figures cannot be tied to any device; on-site clinical testing, not home use.",
   "sources": [
    {
     "label": "PubMed abstract, PMID 25046332",
     "url": "https://pubmed.ncbi.nlm.nih.gov/25046332/",
     "publisher": "U.S. National Library of Medicine",
     "verified": "2026-10-21"
    }
   ],
   "metrics": [
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_onsite_vs_lab_routine",
     "study_type_label": "Independent study, on-site test vs routine laboratory methods",
     "metric_label": "Sensitivity",
     "value_percent": 79,
     "denominator": "Not stated in the abstract",
     "near_cutoff": null,
     "reference_method": "Routine laboratory methods (as described in the abstract)",
     "sponsor": "Independent academic authors (Karolinska Institutet); funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/25046332/",
     "source_page": "Abstract, Results (PubMed 25046332)",
     "tier": "Unverified",
     "context": "Study-specific figure. The accessible abstract does not name the on-site product, so it cannot be matched to any device; not evidence about home kits."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_onsite_vs_lab_routine",
     "study_type_label": "Independent study, on-site test vs routine laboratory methods",
     "metric_label": "Specificity",
     "value_percent": 96,
     "denominator": "Not stated in the abstract",
     "near_cutoff": null,
     "reference_method": "Routine laboratory methods (as described in the abstract)",
     "sponsor": "Independent academic authors (Karolinska Institutet); funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/25046332/",
     "source_page": "Abstract, Results (PubMed 25046332)",
     "tier": "Unverified",
     "context": "Study-specific figure. The accessible abstract does not name the on-site product, so it cannot be matched to any device; not evidence about home kits."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_onsite_vs_lab_routine_lab_arm",
     "study_type_label": "Independent study, laboratory arm",
     "metric_label": "Overall agreement, laboratory study",
     "value_percent": 95,
     "denominator": "Not stated in the abstract",
     "near_cutoff": null,
     "reference_method": "Routine laboratory methods (as described in the abstract)",
     "sponsor": "Independent academic authors (Karolinska Institutet); funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/25046332/",
     "source_page": "Abstract, Results (PubMed 25046332)",
     "tier": "Unverified",
     "context": "Study-specific figure. The accessible abstract does not name the on-site product, so it cannot be matched to any device; not evidence about home kits."
    },
    {
     "analyte": "ALL",
     "cutoff_ng_ml": null,
     "matrix": "urine",
     "study_type": "independent_onsite_vs_lab_routine_clinic_arm",
     "study_type_label": "Independent study, dependency-clinic arm",
     "metric_label": "Overall agreement, clinical study",
     "value_percent": 98,
     "denominator": "Not stated in the abstract",
     "near_cutoff": null,
     "reference_method": "Routine laboratory methods (as described in the abstract)",
     "sponsor": "Independent academic authors (Karolinska Institutet); funding not stated in the abstract",
     "source_url": "https://pubmed.ncbi.nlm.nih.gov/25046332/",
     "source_page": "Abstract, Results (PubMed 25046332)",
     "tier": "Unverified",
     "context": "Study-specific figure. The accessible abstract does not name the on-site product, so it cannot be matched to any device; not evidence about home kits."
    }
   ],
   "card": {
    "group": "research",
    "tags": [
     "Independent study",
     "No product named"
    ],
    "evidence": "Independent study; product not named (unverified)",
    "analytes": "Pooled across drug classes",
    "cutoff": "Not stated in the abstract",
    "source": 0,
    "ref": "Scand J Clin Lab Invest · 2014 · PMID 25046332",
    "use_short": "On-site testing in a lab and a clinic"
   }
  }
 ]
}