Ontrak Teststik for Methamphetamine, Cat. 1986686
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K000096 FDA 510(k)
- FDA Product Code
- LAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3610 FDA 510(k)
- Regulation Number
- 862.3610 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ontrak Teststik for Methamphetamine is a Class II medical device classified as Gas Chromatography, Methamphetamine. It is designed for the detection of methamphetamine in clinical laboratory settings. The device is manufactured by Roche Diagnostics Corp. and is part of the company's clinical toxicology product line.
The Ontrak Teststik for Methamphetamine is supplied as a single-use device and is regulated under FDA 510(k) clearance K000096, with a decision date of April 26, 2000. It is classified under product code LAF and regulation number 862.3610. The device is intended for use in clinical toxicology settings and is not indicated for MRI compatibility.
Frequently asked questions
What is the Ontrak Teststik for Methamphetamine used for?
The Ontrak Teststik for Methamphetamine is designed for the detection of methamphetamine in clinical laboratory settings. It is a Class II medical device classified as Gas Chromatography, Methamphetamine, intended for use in clinical toxicology.
How is the Ontrak Teststik supplied and is it reusable?
The Ontrak Teststik for Methamphetamine is supplied as a single-use device. This means it is designed for one-time use only and should not be reused or repurposed after initial use to ensure accurate test results and maintain safety standards.
What is the regulatory status of the Ontrak Teststik for Methamphetamine?
The Ontrak Teststik for Methamphetamine is regulated under FDA 510(k) clearance K000096 with a decision date of April 26, 2000. It is classified under product code LAF and regulation number 862.3610, and is not indicated for MRI compatibility.
Who manufactures the Ontrak Teststik for Methamphetamine?
The Ontrak Teststik for Methamphetamine is manufactured by Roche Diagnostics Corp., which is located in Indianapolis, Indiana. The device is part of the company's clinical toxicology product line and is produced under FDA 510(k) clearance.
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: K000096 - ONTRAK TESTSTIK FOR METHAMPHETAMINE | FDA 510(k), Ontrak Teststik for Methamphetamine, Cat. 1986686, ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 510 (k) K000096 - FDA ..., K000096 - ONTRAK TESTSTIK FOR METHAMPHETAMINE | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K000096 | 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) K000096 24 fields · synced Sep 21, 2026