# K992890: Roche Cobas Integra Opiates 300/2000

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 23, 1999 after 88 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935550 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974840: Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Indications for use
The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine.

Source page: https://510kreport.com/device/K992890
Methodology: https://510kreport.com/methodology