Roche Abuscreen Online for Methadone
by Roche Diagnostic Systems, Inc. 510(k)
Active
510(k) K930928
Overview
The Roche Abuscreen Online for Methadone is an enzyme immunoassay device designed for the qualitative and semiquantitative detection of methadone in human urine. Classified as an in vitro diagnostic test, it operates on Roche/Hitachi cobas c systems to identify methadone presence at a cutoff concentration of 300 ng/mL. This assay supports clinical toxicology assessments by providing measurable results to evaluate assay performance and quality control.
Supplied as a single-use reagent for laboratory use, the device requires compatibility with Roche/Hitachi cobas c systems. It is intended for use in clinical settings where urine testing for methadone is necessary, adhering to regulatory standards outlined in FDA 510(k) clearance (K930928). The device is not MRI-safe, and storage conditions must align with manufacturer guidelines for in vitro diagnostics. Authorized under FDA 510(k) clearance, it falls under the classification of Class II medical devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930928 | Date24 Sep 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DJR
- 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 is the Roche Abuscreen Online for Methadone used for?
The Roche Abuscreen Online for Methadone is an enzyme immunoassay designed specifically for the qualitative and semiquantitative detection of methadone in human urine samples. It supports clinical toxicology assessments by providing measurable results to evaluate methadone presence, aiding in patient monitoring and treatment decisions in clinical settings.
How is the Roche Abuscreen Online for Methadone supplied and used?
This device is supplied as a single-use reagent intended exclusively for laboratory use. It operates on Roche/Hitachi cobas c systems, ensuring compatibility with these platforms for accurate and reliable methadone detection. Each reagent is designed for one-time use only, adhering to standard laboratory protocols for in vitro diagnostics.
Is the Roche Abuscreen Online for Methadone sterile and single-use?
Yes, the Roche Abuscreen Online for Methadone is supplied as a single-use reagent, which means each unit is intended for one test only. While the device itself is not explicitly described as sterile in the provided data, it follows standard practices for in vitro diagnostics where single-use reagents are typically sterile or terminally sterilized to ensure safety and reliability in clinical settings.
What cutoff concentration does the Roche Abuscreen Online for Methadone detect?
The device detects methadone at a cutoff concentration of 300 ng/mL in human urine. This cutoff ensures that results are both sensitive and specific for clinical decision-making, helping clinicians assess methadone presence within the defined threshold.
What storage conditions should be followed for the Roche Abuscreen Online for Methadone?
Storage conditions for the Roche Abuscreen Online for Methadone must align with the manufacturer’s guidelines for in vitro diagnostics. While specific storage details like temperature or humidity are not provided, it is critical to follow the instructions included with the device to maintain its integrity and performance. Improper storage could compromise test accuracy.