# K021512: Cobas Integra Online Dat II Methadone II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 16, 2002 after 68 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951595 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Indications for use
The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Source page: https://510kreport.com/device/K021512
Methodology: https://510kreport.com/methodology