Roche Abuscreen Ontrak for Methadone
by Roche Diagnostic Systems, Inc. 510(k)
Active
510(k) K930845
Overview
The Roche Abuscreen Ontrak for Methadone is a Hemagglutination Inhibition test designed for the qualitative detection of methadone in biological specimens. It falls under the category of clinical toxicology assays, providing a rapid, non-instrumental method for identifying methadone use in urine or serum samples without requiring specialized laboratory equipment.
This device is supplied as a single-use diagnostic kit, intended for use in clinical or forensic settings where rapid, on-site testing is required. It is not sterile and must be handled in accordance with standard laboratory practices. The test is regulated under FDA 510(k) clearance (K930845) and classified as a Class II medical device, adhering to regulatory standards for hemagglutination inhibition assays. Storage and handling instructions are specified in the accompanying documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930845 | Date20 Apr 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DIW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3620
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Roche Diagnostic Systems, Inc.
Questions
What types of biological samples can the Roche Abuscreen Ontrak for Methadone test for methadone presence, and how quickly can results be obtained?
The Roche Abuscreen Ontrak for Methadone is designed to detect methadone in urine or serum samples. It uses a hemagglutination inhibition method, which allows for rapid, non-instrumental testing—typically yielding results within minutes without requiring specialized lab equipment. This makes it ideal for on-site or point-of-care use in clinical or forensic settings.
Is the Roche Abuscreen Ontrak for Methadone kit reusable, and what precautions should be taken during handling?
The kit is single-use only and is not sterile, so it must be handled following standard laboratory practices to avoid contamination. Since it’s designed for qualitative detection of methadone, each test should be performed with a fresh kit to ensure accuracy and prevent cross-contamination between samples.
What regulatory pathway does the Roche Abuscreen Ontrak for Methadone follow, and how does this affect its use?
The device follows the FDA 510(k) clearance pathway, specifically under clearance number K930845, and is classified as a Class II medical device. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets regulatory standards for hemagglutination inhibition assays in clinical toxicology. Clinicians can rely on its compliance with FDA requirements for use in detecting methadone in biological specimens.
Where should the Roche Abuscreen Ontrak for Methadone kit be stored, and are there specific conditions mentioned?
Storage instructions are detailed in the accompanying documentation, though the data provided does not specify exact conditions. Generally, such diagnostic kits should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Always refer to the included instructions for precise storage guidelines to maintain test validity.