FDA 510(k) record · Over the counter
UCP Home Drug Screening Test Cards and Cup
An older FDA-cleared home urine screen. The FDA decision summary includes a sponsor-run lay-user study with results for each drug at six concentrations.
Read this first
P in the Cup does not perform the testing or certify these products. The figures below come from one source document and describe one study design. They are not a general accuracy rating, and a home screen result is preliminary until a laboratory confirms it. See what accuracy figures mean.
Identity
Exactly what this record covers
| Field | As stated in the source |
|---|---|
| Device | UCP Home Drug Screening Test Cards; UCP Home Drug Screening Test Cup |
| Applicant | UCP Biosciences Inc. |
| 510(k) number | K091588 (FDA database record) |
| Decision | Substantially equivalent, decision date 4 September 2009 (received 2 June 2009) |
| Purpose of submission | Adds an over-the-counter claim to devices already cleared for prescription use (K050540, K061457; cup format K072062). The summary says this is "the exact same device as the predicate device" (PDF page 4). |
| Intended use | Over-the-counter users as the first step in a two-step process, and health care professional users. Includes materials for shipping a urine specimen to a laboratory for confirmation (PDF page 3). |
| Sample type | Human urine |
| Test type | Qualitative immunochromatographic (lateral flow) tests; read time 5 to 10 minutes |
| Formats | Test card holds up to 10 strips; test cup up to 5 strips, one drug per strip (PDF page 3) |
| Analytes and cutoffs (ng/mL) | AMP 1,000; BAR 300; BZO 300; COC 300; THC 50; MTD 300; MET 1,000; MDMA 500; Morphine 300; Opiate 2000 2,000; OXY 100; PCP 25; TCA 1,000 (PDF pages 2-3) |
| Buy link | No verified retailer link. No retailer listing has been matched to this exact device and SKU. |
| Last reviewed | 21 October 2026 |
Analyte-level results
Lay-user study, spiked urine
Study design as stated on PDF page 6: 115 lay users tested the card and 110 tested the cup, at three locations (Texas, Pennsylvania, California), none with prior experience of point-of-care drug tests. Drug was spiked into drug-free urine at 0%, 50%, 75%, 125%, 150% and 300% of each cutoff; concentrations were verified by GC/MS (HPLC for TCA). The summary reports 456 observations for each format.
What "total agreement" means here
The share of lay-user readings that matched the expected result for these prepared samples, in this one sponsor study. Most samples were far from the cutoff, where readings are easy; at 75% and 125% of the cutoff agreement drops. It is not clinical sensitivity or specificity (the summary lists clinical studies as "not applicable") and it is not a claim about any other product, brand or lot.
| Analyte | Cutoff (ng/mL) | Agreement at 0 / 50 / 75 / 125 / 150 / 300% of cutoff | Total agreement (stated) | Readings correct | Reference | Tier | Source page / table |
|---|---|---|---|---|---|---|---|
| AMP | 1,000 | 100 / 100 / 94.4 / 94.4 / 100 / 100% | 99.1% | 226/228 readings | GC/MS | B | PDF page 6, table "UCP Home Drug Screening Test Card" |
| BAR | 300 | 100 / 100 / 83.3 / 88.9 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 6, table "UCP Home Drug Screening Test Card" |
| BZO (row "BENZO") | 300 | 100 / 100 / 100 / 77.8 / 100 / 100% | 98.2% | 225/229 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| COC | 300 | 100 / 100 / 88.9 / 83.3 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| MTD (row "Methadone") | 300 | 100 / 100 / 94.7 / 94.4 / 100 / 100% | 99.1% | 226/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| MET (row "Methamp") | 1,000 | 100 / 100 / 88.9 / 88.9 / 100 / 100% | 98.2% | 224/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| MDMA | 500 | 100 / 100 / 83.3 / 77.8 / 100 / 100% | 96.9% | 221/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| MOP (row "Morphine") | 300 | 100 / 100 / 83.3 / 83.3 / 100 / 100% | 97.4% | 222/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| OXY (row "Oxycod.") | 100 | 100 / 100 / 88.9 / 77.8 / 100 / 100% | 97.4% | 222/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| OPI (row "Opiates (Morphine") | 2,000 | 100 / 100 / 83.3 / 83.3 / 100 / 100% | 97.4% | 224/230 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| PCP | 25 | 100 / 100 / 94.4 / 88.9 / 100 / 100% | 98.7% | 225/228 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| TCA | 1,000 | 100 / 100 / 88.9 / 88.9 / 100 / 100% | 98.2% | 224/228 readings | HPLC | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| THC | 50 | 100 / 100 / 88.9 / 88.9 / 100 / 100% | 98.2% | 226/230 readings | GC/MS | B | PDF page 7, table "UCP Home Drug Screening Test Card" |
| Analyte | Cutoff (ng/mL) | Agreement at 0 / 50 / 75 / 125 / 150 / 300% of cutoff | Total agreement (stated) | Readings correct | Reference | Tier | Source page / table |
|---|---|---|---|---|---|---|---|
| AMP | 1,000 | 100 / 100 / 83.3 / 88.9 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| BAR | 300 | 100 / 100 / 77.8 / 83.3 / 100 / 100% | 96.9% | 221/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| BZO (row "BENZO") | 300 | 100 / 100 / 94.4 / 77.8 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| COC | 300 | 100 / 100 / 88.9 / 83.3 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| MTD (row "Methadone") | 300 | 100 / 100 / 88.9 / 88.9 / 100 / 100% | 98.2% | 224/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| MET (row "Methamp") | 1,000 | 100 / 100 / 88.8 / 83.3 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| MDMA | 500 | 100 / 100 / 83.2 / 83.3 / 100 / 100% | 97.4% | 222/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| MOP (row "Morphine") | 300 | 100 / 100 / 83.2 / 83.3 / 100 / 100% | 97.4% | 222/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| OXY (row "Oxycod.") | 100 | 100 / 100 / 88.9 / 83.3 / 100 / 100% | 97.8% | 223/228 readings | GC/MS | B | PDF page 8, table "UCP Home Drug Screening Test Cups" |
| OPI (row "Opiates (Morphine") | 2,000 | 100 / 100 / 83.3 / 83.3 / 100 / 100% | 97.4% | 224/230 readings | GC/MS | B | PDF pages 8-9, table "UCP Home Drug Screening Test Cups" |
| PCP | 25 | 100 / 100 / 84.2 / 83.3 / 100 / 100% | 97.4% | 222/228 readings | GC/MS | B | PDF page 9, table "UCP Home Drug Screening Test Cups" |
| TCA | 1,000 | 100 / 100 / 77.8 / 83.3 / 100 / 100% | 96.9% | 221/228 readings | HPLC | B | PDF page 9, table "UCP Home Drug Screening Test Cups" |
| THC | 50 | 100 / 100 / 83.3 / 77.8 / 100 / 100% | 96.9% | 221/228 readings | GC/MS | B | PDF page 9, table "UCP Home Drug Screening Test Cups" |
"Readings correct" is our sum of the table's own per-concentration counts (negatives at 0%, 50% and 75%; positives at 125%, 150% and 300%). Source percentages are shown exactly as printed.
Where the printed figures and the counts disagree
- Test card, BZO: The table states 98.2%; its own counts give 98.3%.
- Test card, MTD: At 75% of cutoff the table prints 94.7%; its counts (17 of 18) give 94.4%.
- Test card, THC: The table states 98.2%; its own counts give 98.3%.
- Test cup, MET: At 75% of cutoff the table prints 88.8%; its counts (16 of 18) give 88.9%.
- Test cup, MDMA: At 75% of cutoff the table prints 83.2%; its counts (15 of 18) give 83.3%.
- Test cup, MOP: At 75% of cutoff the table prints 83.2%; its counts (15 of 18) give 83.3%.
- Test cup, PCP: At 75% of cutoff the table prints 84.2%; its counts (15 of 18) give 83.3%.
We show the printed figure and the count side by side rather than correct the source. Analytical performance (precision, cutoff, specificity) is not in this summary; it refers to the predicate submissions K050540 and K061457, which we have not extracted.
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.
- Cleared in 2009. Nothing here shows that products sold today under this or any other name are the same device or perform the same way.
- Spiked samples in a controlled study are not the same as real urine from people who have used drugs.
- White-label or resold products need documentary proof that they are this exact cleared device before this record applies to them.
Sources
- FDA 510(k) decision summary K091588 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- FDA 510(k) database record K091588 (U.S. Food and Drug Administration; opened and read 2026-10-21).
General education only, not medical, legal or purchasing advice. Found an error? See the corrections log.
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