# K974695: Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: May 21, 1998 after 156 days
- Product code: CKB (Acid Phosphatase, Naphthyl Phosphate)
- Device class: 2
- Regulation: 21 CFR 862.1020
- 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 K831834 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831834: Raichem Acid Phasphatase Reagent, Reagents Applications, Inc. (1983) Summary page 3.
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 3.

## Indications for use
The cassette COBAS INTEGRA Acid / Prostatic Phosphatase contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of total and prostatic acid phosphatase in serum. The cassette Roche COBAS INTEGRA Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the semi-quantitative detection of benzodiazepines in human urine using the enzyme B-glucuronidase.

Source page: https://510kreport.com/device/K974695
Methodology: https://510kreport.com/methodology