FDA 510(k) record · Over the counter
Healstone Accurate Drug of Abuse Urine Test Cup
An FDA-cleared drug test cup. Clearance is verified; the FDA decision summary linked from the record contains no performance data.
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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 | Healstone Accurate Drug of Abuse Urine Test Cup; Healstone Accurate Drug of Abuse Urine Test Cup Rx |
| Applicant | Healstone Biotech, Inc., Vancouver, Canada (correspondent: LSI International, Inc.) |
| 510(k) number | K221871 (FDA database record) |
| Decision | Substantially equivalent, decision date 30 August 2022 (received 28 June 2022); classification "Test, Amphetamine, Over The Counter" (product code NFT, 21 CFR 862.3100) |
| Intended use | The Accurate cup is for over-the-counter use; the Accurate cup Rx is for prescription use (applicant's 510(k) summary, page 3 of the summary / PDF page 9) |
| Sample type | Human urine |
| Analytes and cutoffs (ng/mL) | AMP 1,000 or 500; BUP 10; BAR 300; BZO 300; COC 300 or 150; EDDP 300; MET 1,000 or 500; MDMA 500; OPI/MOP 2,000 or 300; MTD 300; OXY 100; PCP 25; PPX 300; TCA 1,000; THC 50. "May contain any combination" (indications for use, PDF page 3) |
| Predicate | Healstone Accurate Multi Panel Drug Urine Test Cup, K191841 |
| Buy link | No verified retailer link. No retailer listing has been matched to this exact device and SKU. |
| Last reviewed | 21 October 2026 |
Performance data
Published analytical data in linked review: not available
The FDA decision summary for K221871 (one page) says the 510(k) was reviewed under FDA's Triage-Quick Review Program and refers readers to the applicant's 510(k) summary. It contains no sensitivity, specificity, agreement or near-cutoff figures, so this record shows none.
The applicant's own 510(k) summary, linked from the same FDA record (42-page PDF), contains sections on precision, specificity, method comparison and a lay-user study (it describes 280 participants across two cup configurations, PDF page 38). We have not yet extracted or verified any figures from it, so none are published here. Until a reviewer completes that work, this record's performance tier is Unverified.
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.
- Clearance applies to the device in this record. Retail or white-label cups need documentary proof that they are this exact device before this record applies to them.
- Cutoffs vary by configuration (for example AMP 1,000 or 500 ng/mL); check the cutoff printed on the exact product.
Sources
- FDA 510(k) database record K221871 (U.S. Food and Drug Administration; opened and read 2026-10-21).
- FDA decision summary K221871 (Triage-Quick Review) (U.S. Food and Drug Administration; opened and read 2026-10-21).
- Applicant's 510(k) summary and FDA letter, K221871 (U.S. Food and Drug Administration (applicant document); opened and read 2026-10-21).
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