# K982551: Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum Barbiturates Calibrators, Roche Cobas in

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Aug 18, 1998 after 27 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: 1 generation back to K883730 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890690: Adx TM Barbiturates, Abbott Laboratories (1989) Summary page 2.
- K883730: TDX Benzodiazepines Serum, Abbott Laboratories (1988) Summary page 2.

## Most influential descendants
- K991440: Roche Cobas Integra Serum Barbiturates (1999), 0 descendants of its own

## Indications for use
The cassette COBAS INTEGRA Serum Barbiturates contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose. The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Barbiturates on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of barbiturates in human specimens. The cassette COBAS INTEGRA Serum Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of benzodiazepines and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose. The Abuscreen ONLINE Serum Benzodiazepines Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Benzodiazepines on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of benzodiazepines in human specimens.

Source page: https://510kreport.com/device/K982551
Methodology: https://510kreport.com/methodology