510(k) · Cleared

Cleared

Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin

K961824510(k) TraditionalCleared Jul 23, 199674-day reviewClass II21 CFR 866.5040

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. · DCF Albumin, Antigen, Antiserum, Control

Cleared on Jul 23, 1996 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) and 2 other predicates after a 74-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Jul 23, 1996
Review: 74 days
Class: Class II
Product code: DCF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K860894 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
This deviceK961824 Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc. · 1996
Descendant · cites it directly · 0 of its ownK990992 Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990992Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860894	Behring Nephelometer System	Behring Diagnostics, Inc.	1986	—
0 (this device)	K961824	Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin	Roche Diagnostic Systems, Inc.	1996	—
+1	K990992	Integra Reagent Cassette for Hemoglobin Alc	Roche Diagnostics Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K961824, 1986–1999Source: 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 DCF? 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? (3)

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
*	K860894	Behring Nephelometer System Summary page 2 …ory\|CFR Predicate Date Predicate Name Class ClassificationProduct Predicate [510(k) Number Name Cleared Number COBAS INTEGRA \|Albumin Class II 966.5040 Behring N 4/15/86 K860894 Albumin (ALB-T) \|immunological Antiserum (o (Turbidimetric) test system Human Albumin COBAS INTEGRA \|Glycosylated Class II 864.74…	Behring Diagnostics, Inc.	1986	—
*	K952337	Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P Summary page 1 …4/15/86 K8608%4 Albumin (ALB-T) \|immunological Antiserum to (Turbidimetric) test system Human Albumin COBAS INTEGRA \|Glycosylated Class II 864.7470 Roche Unimate 2/9/96 K952337/S81 HbAlc (HBA1C) hemoglobin HBAI1c Reagent assay COBAS INTEGRA [Digoxin test Class II 862.3320 COBAS INTEGRAJ9/8/95 K951595 Digo…	Roche Diagnostic Systems, Inc.	1996	2
*	K951595	Roche Cobas Integra Analyzer, Reagent Cassettes Summary page 1 …lated Class II 864.7470 Roche Unimate 2/9/96 K952337/S81 HbAlc (HBA1C) hemoglobin HBAI1c Reagent assay COBAS INTEGRA [Digoxin test Class II 862.3320 COBAS INTEGRAJ9/8/95 K951595 Digoxin (DIG) system Digoxin modification Roche Diagnostic Systems, Inc. Somerville, New Jersey 08876 May 1996…	Roche Diagnostic Systems, Inc.	1995	7
†	K954992	Roche Cobas Integra Reagent Cassettes	Roche Diagnostic Systems, Inc.	1996	—

Also cleared against K860894: 16 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990992	Integra Reagent Cassette for Hemoglobin Alc	Roche Diagnostics Corp.	1999	0

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?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K990992 (Roche Diagnostics Corp., 1999) has gone furthest, with 0 descendants of its own.
16 other devices also cite its predicate K860894.

How does its category compare?

All DCF devices

DCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCF

1in 2016

2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCF

167in 2010

2007high 167 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DCF

1in 2019

2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · DCF

12in 2025

2007high 12 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	1
2009	1	—	0	0
2010	3	167	0	0
2011	1	—	0	0
2012	1	—	0	0
2013	1	—	0	0
2014	1	—	0	0
2015	1	—	0	0
2016	1	—	0	0
2017	0	—	0	3
2018	0	—	0	2
2019	0	—	1	6
2020	0	—	0	2
2021	0	—	0	3
2022	0	—	0	3
2023	0	—	0	5
2024	0	—	0	9
2025	0	—	0	12
2026	0	—	0	—

What is it indicated for?

The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine. The COBAS INTEGRA Cassette for Hemoglobin A1c contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbA1c%) in hemolysate.

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/K961824 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961824: Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961824

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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