# K991440: Roche Cobas Integra Serum Barbiturates

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 22, 1999 after 57 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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 K883730 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982551: Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas in, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Indications for use
The cassette COBAS Integra Serum Barbiturates contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.

Source page: https://510kreport.com/device/K991440
Methodology: https://510kreport.com/methodology