510(k) · Cleared

Recalled · 2010

Cobas Integra Reagent Cassettes & Ancillary Reagents

K963292510(k) TraditionalCleared Oct 31, 199671-day reviewClass II21 CFR 862.1145Recalls 2

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. · CIC Cresolphthalein Complexone, Calcium

Cleared on Oct 31, 1996 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) and 7 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it. It has been recalled 2 times.

Decided: Oct 31, 1996
Review: 71 days
Class: Class II
Product code: CIC
Recalls: 2
Predicates: 8

Its longest line of descent runs back 1 generation to K850281 (1985). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK850281 CalciumBoehringer Mannheim Corp. · 1985
This deviceK963292 Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996
Descendant · cites it directly · 0 of its ownK031650 Ferritin Generation 2Roche Diagnostics Corp. · 2003

Most influential descendants

Showing 1 of 1 · See all

K031650Ferritin Generation 2Roche Diagnostics Corp. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850281	Calcium	Boehringer Mannheim Corp.	1985	—
0 (this device)	K963292	Cobas Integra Reagent Cassettes & Ancillary Reagents	Roche Diagnostic Systems, Inc.	1996	—
+1	K031650	Ferritin Generation 2	Roche Diagnostics Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1990	1	0
1994	2	0
1995	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K963292, 1985–2003Source: 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 CIC? 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

Get a 510(k) Report

What was it cleared against? (8)

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
*	K951595	Roche Cobas Integra Analyzer, Reagent Cassettes Summary page 1 …dicate Name Class ClassificationProduct Predicate [510(k) Number Name Cleared Number Chemistry Panel COBAS INTEGRA \|[Calcium test Class II 862.1145 COBAS INTEGRAJ9/5/95 K951595 Calcium system Calcium (modification) Boehringer 1/23/85 K850281 Mannheim Calcium Reagent Immunology Panel COBAS INTEGRA {Anti…	Roche Diagnostic Systems, Inc.	1995	7
*	K850281	Calcium Summary page 1 …ame Cleared Number Chemistry Panel COBAS INTEGRA \|[Calcium test Class II 862.1145 COBAS INTEGRAJ9/5/95 K951595 Calcium system Calcium (modification) Boehringer 1/23/85 K850281 Mannheim Calcium Reagent Immunology Panel COBAS INTEGRA {Antithrombin III \|Class II 866.7060 Berichrom 4/19/94 K933125 Antithro…	Boehringer Mannheim Corp.	1985	—
*	K933125	Berichrom Antithrombin Iii (a) Summary page 1 …ystem Calcium (modification) Boehringer 1/23/85 K850281 Mannheim Calcium Reagent Immunology Panel COBAS INTEGRA {Antithrombin III \|Class II 866.7060 Berichrom 4/19/94 K933125 Antithrombin III {assay Antithrombin III Reagent 023 Roche Diagnostic Systems, Inc. Somerville, New Jersey 088…	Behring Diagnostics, Inc.	1994	—
*	K950707	N Latex Ferritin Summary page 2 …AS® INTEGRA Reagent Cassettes & Ancillary Reagents 510(k) Premarket Notification August 1996 Summary COBAS INTEGRA \|Ferritin Class 11 866.5340 Behring N Latex \|3/27/95 K950707 Ferritin immunological Ferritin Reagent test system COBAS INTEGRA \|Myoglobin Class II 866.5680 Behring N Latex \|6/01/96 K902154…	Behring Diagnostics, Inc.	1995	—
*	K902154	NA Latex Myoglobin Test Summary page 2 …ss 11 866.5340 Behring N Latex \|3/27/95 K950707 Ferritin immunological Ferritin Reagent test system COBAS INTEGRA \|Myoglobin Class II 866.5680 Behring N Latex \|6/01/96 K902154 Myoglobin immunological Myoglobin test system Reagent COBAS INTEGRA [Rheumatoid Class II 866.5775 Behring N Latex \|10/20/94 K942…	Behring Diagnostics, Inc.	1990	—
*	K942328	N Latex RF Summary page 2 …I 866.5680 Behring N Latex \|6/01/96 K902154 Myoglobin immunological Myoglobin test system Reagent COBAS INTEGRA [Rheumatoid Class II 866.5775 Behring N Latex \|10/20/94 K942328 Rheumatoid Factors {factor RF Reagent immunological test system Plasmachrom Calibrator Class II 862.1150 Behring N Protein [4/7/8…	Behring Diagnostics, Inc.	1994	—
*	K883662	Berichrom (R) Antithrombin Iii Summary page 2 …775 Behring N Latex \|10/20/94 K942328 Rheumatoid Factors {factor RF Reagent immunological test system Plasmachrom Calibrator Class II 862.1150 Behring N Protein [4/7/88 K883662 Calibrator Standard Plasma Plasmachrom Quality control \|Class I 862.1660 N/T Protein 4/17/96 K951012 Controls material (assayed C…	Behring Diagnostics, Inc.	1988	—
*	K951012	N/T Protein Control PY Summary page 2 …m Plasmachrom Calibrator Class II 862.1150 Behring N Protein [4/7/88 K883662 Calibrator Standard Plasma Plasmachrom Quality control \|Class I 862.1660 N/T Protein 4/17/96 K951012 Controls material (assayed Control Py and unassaved) Roche FERR T Calibrator Class II 862.1150 Behring N Ferritin {3/27/95 K95070…	Behring Diagnostics, Inc.	1995	—

Also cleared against K951595: 31 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
K031650	Ferritin Generation 2	Roche Diagnostics Corp.	2003	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 11, 2010	Not classified	Z-1824-2011	Other	Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected…
Oct 11, 2010	Not classified	Z-1823-2011	Other	The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 8 ancestors has a recall of any class.
Of its descendants, K031650 (Roche Diagnostics Corp., 2003) has gone furthest, with 0 descendants of its own.
31 other devices also cite its predicate K951595.

How does its category compare?

All CIC devices

CIC Cresolphthalein Complexone, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIC

1in 2013

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIC

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

Recalls per year · CIC

1in 2016

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CIC

10in 2025

2007high 83 (2010) · low 0 (2007)2025

MAUDE reports naming product code CIC, 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	1	—	0	0
2008	0	—	0	0
2009	1	—	3	5
2010	0	—	2	83
2011	0	—	0	29
2012	0	—	0	10
2013	1	—	0	4
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	1	30
2017	0	—	0	6
2018	0	—	0	42
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	4
2024	0	—	0	8
2025	0	—	0	10
2026	0	—	0	—

What is it indicated for?

Read the full statement (269 words)

The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYO T Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.

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/K963292 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963292: Cobas Integra Reagent Cassettes & Ancillary Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963292

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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