Test Kit Research & Comparison Center
FDA 510(k) records
What an FDA clearance tells you about a drug test, what it does not, and where to read the record yourself.
What a 510(k) clearance is
A 510(k) is a premarket notification. FDA uses it to determine whether a new device is substantially equivalent to a device already legally on the market (the "predicate"). FDA describes the pathway as applying to low- to moderate-risk devices with a legally marketed predicate, and says the 510(k) review standard is comparative, whereas premarket approval (PMA) relies on an independent demonstration of safety and effectiveness.
FDA's drugs of abuse tests page lists the common test types as Class II devices and publishes decision summaries for tests "cleared by the FDA for marketing".
What it is not
- Cleared is not approved. "Approved" refers to PMA. A seller calling a 510(k)-cleared drug test "FDA approved" is using the wrong word. Ask which FDA record supports the claim and read it.
- Registered is not cleared. FDA says registration of a facility does not denote approval, clearance or authorization of that facility or its devices, and that FDA does not issue device registration certificates. A certificate bearing an FDA logo is not an FDA document.
- Not a ranking. Substantial equivalence is a comparison with a predicate, not a finding that one test is more accurate than another.
- Not a guarantee for every sample. A cleared screen still gives preliminary results that need laboratory confirmation.
- Not a guarantee for every box with a similar name. A clearance applies to the device in the record. FDA notes that the same test is sometimes sold under different brand names, and white-label or resold kits are common. Before we link any retail product to a clearance we need documentary evidence (for example the manufacturer's labelling naming the 510(k) number) that it is that exact device. We have not matched any retail product so far.
- Intended use matters. Read who the clearance is for. K091612 is for prescription use in point-of-care settings; it does not cover home use.
Where performance data is, and is not
The FDA 510(k) database record shows the device name, applicant, decision date, product codes and links to documents. Analyte-level performance tables, where published, are in the decision summary PDF, and sometimes in the applicant's 510(k) summary. The openFDA 510(k) API describes its data as details about products and sponsors plus administrative and tracking information such as receipt and decision dates; it does not describe performance tables, so it cannot be used to generate accuracy ratings without reading the documents. openFDA also says not to rely on it for decisions about medical care.
Some decision summaries contain no performance data at all. The one for K221871 is a one-page note saying the submission went through FDA's Triage-Quick Review Program.
Audit trail
FDA records we have read
Each record was opened at FDA on 21 October 2026. Decision dates and applicants are as shown in FDA's 510(k) database.
| 510(k) | Device | Applicant | Decision date | Intended use | Performance data in FDA decision summary | FDA documents |
|---|---|---|---|---|---|---|
| K091588 | UCP Home Drug Screening Test Cards; UCP Home Drug Screening Test Cup | UCP Biosciences, Inc. | 4 September 2009 | Over the counter and health care professional use | Yes: lay-user study by analyte and concentration (PDF pages 6-9) | Record; decision summary |
| K091612 | UCP Rapid Drug Screening BUP, AMP 300, mAMP 500 and Cocaine 150 Tests | UCP Biosciences, Inc. | 24 February 2010 | Prescription, point-of-care settings | Yes: reproducibility (PDF pages 5-6), cross-reactivity (pages 7-8), method comparison (pages 9-10) | Record; decision summary |
| K221871 | Healstone Accurate Drug of Abuse Urine Test Cup; Healstone Accurate Drug of Abuse Urine Test Cup Rx | Healstone Biotech, Inc. | 30 August 2022 | Over the counter (cup) and prescription (cup Rx) | Not available: one-page Triage-Quick Review note | Record; decision summary |
K091588 refers to the earlier prescription clearances K050540 and K061457 for its analytical performance data. We have not extracted figures from those documents.
How to check a record yourself
Find the number
Look for a 510(k) number (a K followed by six digits) in the package insert. If the seller only says "FDA approved" or "FDA registered", ask for the number.
Open FDA's database
Search the FDA 510(k) database for that number and check the device name and applicant match the product.
Read the intended use
Check whether it is for over-the-counter (home) use, prescription use, or both, and which drugs and cutoffs it covers.
Read the decision summary
Look for performance tables by drug and concentration, and note who ran the studies.
Sources
- U.S. Food and Drug Administration, "Medical Device Safety and the 510(k) Clearance Process" (content current as of 6 September 2023; read 21 October 2026). Supports: 510(k) determines substantial equivalence to a marketed device; low- to moderate-risk devices with a predicate; the 510(k) standard is comparative, PMA relies on an independent demonstration of safety and effectiveness.
- U.S. Food and Drug Administration, "Device Approvals and Clearances" (read 21 October 2026, as cited in our kit-choosing guide). Supports: "cleared" (510(k)) and "approved" (PMA) are different.
- U.S. Food and Drug Administration, "Drugs of Abuse Tests" (read 21 October 2026). Supports: Class II listing; decision summaries for tests cleared for marketing; the same test is sometimes sold under different brand names.
- U.S. Food and Drug Administration, "Are there 'FDA Registered' or 'FDA Certified' Medical Devices?" (content current as of 3 March 2021; read 21 October 2026). Supports: registration does not denote clearance or approval; FDA issues no registration certificates.
- openFDA, "Device 510(k) API" (read 21 October 2026). Supports: dataset describes products, sponsors and administrative and tracking information; do not rely on openFDA for medical-care decisions.
- FDA 510(k) database records and decision summaries for K091588, K091612 and K221871, linked in the table above (read 21 October 2026). Supports: device names, applicants, decision dates, intended use and the presence or absence of performance data.
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