Ontrak Teststik 2 For Cocaine/Thc, Cat. 1118579
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994164 FDA 510(k)
- FDA Product Code
- LDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3870 FDA 510(k)
- Regulation Number
- 862.3870 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an enzyme immunoassay test for the qualitative detection of cocaine metabolite and cannabinoids in urine. It is designed for professional use and provides results based on established cutoff levels, specifically 300 ng/ml for cocaine metabolite and cannabinoids. The test is intended to be used as an in vitro diagnostic tool to screen urine samples for the presence of these substances.
The device is supplied by Roche Diagnostics Corp. and is regulated under FDA product code LDJ as a Class II device with special controls. It is intended for professional use in clinical or workplace settings and is packaged under catalog number 1118579. The test is single-use and should be stored in a dry environment at room temperature. It is not intended for home use and must be performed by trained personnel following the manufacturer's instructions.
Frequently asked questions
What substances does this test detect and at what cutoff levels?
The device is an enzyme immunoassay designed to qualitatively detect cocaine metabolite and cannabinoids in urine. It uses established cutoff levels of 300 ng/ml for both cocaine metabolite and cannabinoids, providing a screening tool for these specific substances.
Who is authorized to use this device and in what settings?
This test is intended for professional use only and is not designed for home use. It is suitable for clinical or workplace settings and must be performed by trained personnel who follow the manufacturer's instructions to ensure accurate results.
How is the device supplied and what is its catalog number?
The device is supplied by Roche Diagnostics Corp. and is packaged under catalog number 1118579. It is a single-use test, meaning each unit is designed for one application and should not be reused.
What are the storage requirements for this test?
The test should be stored in a dry environment at room temperature. Proper storage conditions are essential to maintain the integrity of the enzyme immunoassay components and ensure reliable performance when used.
What regulatory classification does this device hold?
The device is regulated under FDA product code LDJ as a Class II device with special controls. It has received FDA 510K authorization, indicating it has been determined to be substantially equivalent to existing legally marketed devices.
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 TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 by ROCHE DIAGNOSTICS ..., ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 (K994164) — FDA 510(k ..., K994164 FDA 510(k) - ONTRAK TESTSTIK 2 FOR COCAINE/THC, PDF K994164 - Ontrak Teststik 2 for Cocaine/Thc, Cat. 1118579
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994164 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K994164 24 fields · synced Sep 22, 2026