510(k) · Cleared

Cleared

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

K974695510(k) TraditionalCleared May 21, 1998156-day reviewClass II21 CFR 862.1020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostic Systems, Inc. · CKB Acid Phosphatase, Naphthyl Phosphate

Cleared on May 21, 1998 as substantially equivalent to K831834 (Reagents Applications, Inc., 1983) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 1983.

Decided: May 21, 1998
Review: 156 days
Class: Class II
Product code: CKB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K831834 (1983). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK831834 Raichem Acid Phasphatase ReagentReagents Applications, Inc. · 1983
This deviceK974695 Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra…Roche Diagnostic Systems, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K831834	Raichem Acid Phasphatase Reagent	Reagents Applications, Inc.	1983	—
0 (this device)	K974695	Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines…	Roche Diagnostic Systems, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K974695, 1983–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K831834	Raichem Acid Phasphatase Reagent Summary page 3 …s equivalence. Table 2 Product Name Predicate Product Name K number \|Date of substantial equivalence COBAS INTEGRA Acid/ Prostatic Roche Reagent for Acid Phosphatase \|K831834 \|8/26/83 Phosphatase (ACPP) {(OEM from Reagents Applications, inc.) COBAS INTEGRA Benzodiazepines \|COBAS INTEGRA Benzodiazepines…	Reagents Applications, Inc.	1983	—
*	K951595	Roche Cobas Integra Analyzer, Reagent Cassettes Summary page 3 …Reagent for Acid Phosphatase \|K831834 \|8/26/83 Phosphatase (ACPP) {(OEM from Reagents Applications, inc.) COBAS INTEGRA Benzodiazepines \|COBAS INTEGRA Benzodiazepines K951595 \|9/8/95 with B-glucuronidase (BNZGL) (BENZ) IV. Description of the Device/Statement of Intended Use: The COBAS INTEGRA test ap…	Roche Diagnostic Systems, Inc.	1995	7

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.

How does its category compare?

All CKB devices

CKB Acid Phosphatase, Naphthyl Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKB

FDA has decided no CKB device since 2007.

Median 510(k) review, days · CKB

Too few CKB 510(k)s in any year since 2007 to give a median.

Recalls per year · CKB

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CKB

2in 2021

2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code CKB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	2
2012	—	0	1
2013	—	1	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	2
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974695 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974695: Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974695

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026