FDA 510(k) record · Prescription / point of care
UCP Rapid Drug Screening BUP, AMP 300, mAMP 500 and Cocaine 150 Tests
A prescription device for point-of-care settings, not a consumer home kit. Its FDA decision summary shows how readings behave near each cutoff.
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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 Rapid Drug Screening BUP, AMP 300, mAMP 500 and Cocaine 150 Tests |
| Applicant | UCP Biosciences, Inc. (the decision summary spells it "UPC BioSciences, Inc." on PDF page 1; the FDA database record reads "Ucp Biosciences, Inc.") |
| 510(k) number | K091612 (FDA database record) |
| Decision | Substantially equivalent, decision date 24 February 2010 (received 3 June 2009); new device |
| Intended use | In vitro diagnostic prescription use, in point-of-care settings (PDF page 2). Not cleared for over-the-counter home use. |
| Sample type | Human urine |
| Formats | Dip card, cassette (test device) and test cup; 1 to 4 drug strips per device (PDF pages 2-3) |
| Analytes and cutoffs (ng/mL) | Buprenorphine 10; amphetamine 300; methamphetamine 500; cocaine (benzoylecgonine) 150 |
| Predicates | ACON BUP, AMP-300, mAMP-500 and COC-150 One Step tests (K033299, K060466, K041822, K032903) |
| Confirmation | Preliminary results only; GC/MS or LC/MS is the preferred confirmatory method (PDF page 2) |
| 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
Reproducibility near the cutoff
Design as stated on PDF page 5: drug-free urine spiked to negative, 50%, 75%, 125%, 150% and 200% of each cutoff; three point-of-care sites, three operators per site, each testing one format; samples blind-labelled and tested over 10 non-consecutive days, 30 determinations per concentration. The source gives counts, not percentages.
| Analyte | Cutoff (ng/mL) | Format | At 75% of cutoff | At 125% of cutoff | Determinations | Tier | Source page / table |
|---|---|---|---|---|---|---|---|
| AMP | 300 | dip card | 75% of cutoff (225 ng/mL): 20 negative / 10 positive of 30 | 125% of cutoff (375 ng/mL): 11 negative / 19 positive of 30 | 30 determinations per level | B | PDF page 5, table "Amphetamine cutoff 300 ng/mL" |
| AMP | 300 | cassette | 75% of cutoff (225 ng/mL): 19 negative / 11 positive of 30 | 125% of cutoff (375 ng/mL): 12 negative / 18 positive of 30 | 30 determinations per level | B | PDF page 5, table "Amphetamine cutoff 300 ng/mL" |
| AMP | 300 | cup | 75% of cutoff (225 ng/mL): 18 negative / 12 positive of 30 | 125% of cutoff (375 ng/mL): 13 negative / 17 positive of 30 | 30 determinations per level | B | PDF page 5, table "Amphetamine cutoff 300 ng/mL" |
| MET | 500 | dip card | 75% of cutoff (375 ng/mL): 18 negative / 12 positive of 30 | 125% of cutoff (625 ng/mL): 11 negative / 19 positive of 30 | 30 determinations per level | B | PDF page 5, table "Methamphetamine cutoff 500 ng/mL" |
| MET | 500 | cassette | 75% of cutoff (375 ng/mL): 19 negative / 11 positive of 30 | 125% of cutoff (625 ng/mL): 13 negative / 17 positive of 30 | 30 determinations per level | B | PDF page 5, table "Methamphetamine cutoff 500 ng/mL" |
| MET | 500 | cup | 75% of cutoff (375 ng/mL): 18 negative / 12 positive of 30 | 125% of cutoff (625 ng/mL): 11 negative / 19 positive of 30 | 30 determinations per level | B | PDF page 5, table "Methamphetamine cutoff 500 ng/mL" |
| COC | 150 | dip card | 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 | 30 determinations per level | B | PDF page 5, table "Cocaine cutoff 150 ng/mL" |
| COC | 150 | cassette | 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 | 30 determinations per level | B | PDF page 5, table "Cocaine cutoff 150 ng/mL" |
| COC | 150 | cup | 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 | 30 determinations per level | B | PDF page 5, table "Cocaine cutoff 150 ng/mL" |
| BUP | 10 | dip card | 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 | 30 determinations per level | B | PDF page 6, table "Buprenorphine cutoff 10 ng/mL" |
| BUP | 10 | cassette | 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 | 30 determinations per level | B | PDF page 6, table "Buprenorphine cutoff 10 ng/mL" |
| BUP | 10 | cup | 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 | 30 determinations per level | B | PDF page 6, table "Buprenorphine cutoff 10 ng/mL" |
At 0% and 50% of the cutoff every determination read negative, and at 150% and 200% every determination read positive, for all four drugs and formats. In the buprenorphine table the 7.5 ng/mL row is labelled "25%"; 7.5 ng/mL is 75% of the 10 ng/mL cutoff.
Comparison with mass spectrometry on clinical samples
Design as stated on PDF page 9: three operators at one point-of-care site, each testing 80 unaltered clinical samples for each drug on one format, compared with GC/MS or LC/MS/MS. Counts below are from the tables on PDF pages 9-10; the source does not state percentages.
| Analyte | Cutoff (ng/mL) | Format | Overall counts | Near the cutoff | Reference | Tier | Source page / table |
|---|---|---|---|---|---|---|---|
| AMP | 300 | dip card | 80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 9, table "Test Card", row "AMP (300)" |
| AMP | 300 | cassette | 80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cassette", row "AMP (300)" |
| AMP | 300 | cup | 80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cup", row "AMP (300)" |
| MET | 500 | dip card | 80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 9, table "Test Card", row "mAMP (500)" |
| MET | 500 | cassette | 80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cassette", row "mAMP (500)" |
| MET | 500 | cup | 80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cup", row "mAMP (500)" |
| COC | 150 | dip card | 80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 9, table "Test Card", row "COC (150)" |
| COC | 150 | cassette | 80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cassette", row "COC (150)" |
| COC | 150 | cup | 80 samples: 40 of 40 at or above cutoff read positive; 39 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cup", row "COC (150)" |
| BUP | 10 | dip card | 80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 9, table "Test Card", row "BUP (10)" |
| BUP | 10 | cassette | 80 samples: 38 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cassette", row "BUP (10)" |
| BUP | 10 | cup | 80 samples: 39 of 40 at or above cutoff read positive; 40 of 40 below cutoff read negative | 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. | GC/MS or LC/MS/MS | B | PDF page 10, table "Test Cup", row "BUP (10)" |
The summary also reports cross-reactivity (PDF pages 7-8): for example, the amphetamine strip responded at its cutoff to 850 ng/mL D,L-amphetamine and 650 ng/mL MDA, while ephedrine produced no equivalent response below 100,000 ng/mL.
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.
- Studies were run by the sponsor and reviewed by FDA; they are not independent.
- One operator per format in the method comparison, so format-to-format differences cannot be separated from operator differences.
- This record says nothing about consumer retail kits, which need their own over-the-counter clearance.
Sources
- FDA 510(k) decision summary K091612 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- FDA 510(k) database record K091612 (U.S. Food and Drug Administration; opened and read 2026-10-21).
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