Ontrak Testcup 501, Model 3016633
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001421 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ontrak Testcup 501, Model 3016633 is an enzyme immunoassay device designed for the qualitative detection of amphetamine in urine specimens. It functions as an immunoassay test cup, leveraging antibody-antigen interactions to identify the presence of amphetamine metabolites, aiding in clinical toxicology assessments.
This device is intended for single-use in laboratory or clinical settings and requires no sterilization beyond manufacturer-provided packaging. It is classified as a Class II medical device under FDA Special Controls (product code DKZ) and was cleared via a 510(k) submission (K001421) in 2000. The testcup is supplied as a ready-to-use kit and must be stored according to the manufacturer’s instructions to maintain integrity until use.
Frequently asked questions
What is the Ontrak Testcup 501, Model 3016633 used for?
The Ontrak Testcup 501, Model 3016633 is designed for the qualitative detection of amphetamine metabolites in urine specimens. It uses enzyme immunoassay technology to identify the presence of amphetamine, which is useful in clinical toxicology assessments to confirm drug use or exposure.
How is the Ontrak Testcup 501 supplied and prepared for use?
The device is supplied as a ready-to-use kit, meaning no additional preparation beyond unpacking is required before testing. Each test cup is intended for single-use only, ensuring accuracy and reliability for one urine specimen analysis.
Is sterilization required for the Ontrak Testcup 501?
No additional sterilization is required beyond the manufacturer-provided packaging. The test cups are pre-packaged to maintain sterility until use, eliminating the need for external sterilization procedures.
Can the Ontrak Testcup 501 be reused?
No, the Ontrak Testcup 501 is designed for single-use only. Reusing the device could compromise test accuracy and introduce contamination, which is why it is explicitly intended for one-time use per urine specimen.
How should the Ontrak Testcup 501 be stored?
The test cups must be stored according to the manufacturer’s instructions to preserve their integrity until use. Proper storage conditions ensure the device remains effective and reliable for detecting amphetamine metabolites in urine.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ONTRAK TESTCUP 501, MODEL 3016633 (K001421) - FDA 510 (k), Ontrak Testcup 501, Model 3016633 510(k) K001421 - FDA.report, FDA Browser - Cleared 510 (K) - ONTRAK TESTCUP 501, MODEL 3016633 (K001421), PDF K001421 - Ontrak Testcup 501, Model 3016633
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001421 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K001421 24 fields · synced Oct 1, 2026