510(k) · Cleared

Recalled · Class II · 2018

Roche Cobas Ibtegra Reagent Cassettes

K964457510(k) TraditionalCleared Jan 13, 199768-day reviewClass I21 CFR 862.1360Recalls 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. · JQB Kinetic Method, Gamma-Glutamyl Transpeptidase

Cleared on Jan 13, 1997 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) and 5 other predicates after a 68-day review. Its family tree reaches back 1 generation to 1978. 1 later device descends from it. It has been recalled 2 times.

Decided: Jan 13, 1997
Review: 68 days
Class: Class I
Product code: JQB
Recalls: 2
Predicates: 6

Its longest line of descent runs back 1 generation to K780563 (1978). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK780563 Single Vial LactateBoehringer Mannheim Corp. · 1978
This deviceK964457 Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997
Descendant · cites it directly · 0 of its ownK060853 Online TDM TobramycinRoche Diagnostics Corp. · 2006 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K060853Online TDM TobramycinRoche Diagnostics Corp. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K780563	Single Vial Lactate	Boehringer Mannheim Corp.	1978	—
0 (this device)	K964457	Roche Cobas Ibtegra Reagent Cassettes	Roche Diagnostic Systems, Inc.	1997	—
+1	K060853	Online TDM Tobramycin	Roche Diagnostics Corp.	2006	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1985	1	0
1986	1	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K964457, 1978–2006Source: 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 JQB? 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? (6)

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 2 …lence. Product Name Predicate Product Name K number ]date of substantial equivalence COBAS INTEGRA... Gamma-Glutamyitransferase - IFCC Roche COBAS INTEGRA, GGT (TRIS) K951595 9/8/95 Lactate Dehydrogenase - IFCC Roche COBAS INTEGRA, LD K954992 1/25/96 (Lactate - Pyruvate) Total Protein - urine and CSF…	Roche Diagnostic Systems, Inc.	1995	7
*	K954992	Roche Cobas Integra Reagent Cassettes Summary page 2 …tial equivalence COBAS INTEGRA... Gamma-Glutamyitransferase - IFCC Roche COBAS INTEGRA, GGT (TRIS) K951595 9/8/95 Lactate Dehydrogenase - IFCC Roche COBAS INTEGRA, LD K954992 1/25/96 (Lactate - Pyruvate) Total Protein - urine and CSF SIGMA Diagnostics, Microprotein-PR K853681 10/28/95 Lactate Boehrin…	Roche Diagnostic Systems, Inc.	1996	—
*	K853681	Sigma 610 for Protein in Urine & CSF Summary page 2 …1595 9/8/95 Lactate Dehydrogenase - IFCC Roche COBAS INTEGRA, LD K954992 1/25/96 (Lactate - Pyruvate) Total Protein - urine and CSF SIGMA Diagnostics, Microprotein-PR K853681 10/28/95 Lactate Boehringer Mannheim, Lactate K780563 4/18/78 Tobramycin Abbott Diagnostics, TDX / TDX Fiex K802668 11/24/80 T…	Sigma Diagnostics, Inc.	1985	—
*	K780563	Single Vial Lactate Summary page 2 …NTEGRA, LD K954992 1/25/96 (Lactate - Pyruvate) Total Protein - urine and CSF SIGMA Diagnostics, Microprotein-PR K853681 10/28/95 Lactate Boehringer Mannheim, Lactate K780563 4/18/78 Tobramycin Abbott Diagnostics, TDX / TDX Fiex K802668 11/24/80 Tobramycin Immunoglobulin A Behring Diagnostics, N and…	Boehringer Mannheim Corp.	1978	—
*	K802668	Cybrex Tobramycin Summary page 2 …- urine and CSF SIGMA Diagnostics, Microprotein-PR K853681 10/28/95 Lactate Boehringer Mannheim, Lactate K780563 4/18/78 Tobramycin Abbott Diagnostics, TDX / TDX Fiex K802668 11/24/80 Tobramycin Immunoglobulin A Behring Diagnostics, N and NA Reagents \| K860894 4/15/86 Immunoglobulin G BehringDiagnost…	Abbott Laboratories	1980	—
*	K860894	Behring Nephelometer System Summary page 2 …Mannheim, Lactate K780563 4/18/78 Tobramycin Abbott Diagnostics, TDX / TDX Fiex K802668 11/24/80 Tobramycin Immunoglobulin A Behring Diagnostics, N and NA Reagents \| K860894 4/15/86 Immunoglobulin G BehringDiagnostics, N and NA Reagents \| K860894 4/15/86 Immunoglobulin M Behring Diagnostics, N and NA…	Behring Diagnostics, Inc.	1986	—

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
K060853	Online TDM Tobramycin	Roche Diagnostics Corp.	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 17, 2018	Class II	Z-1146-2019	Device Design	New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update…
May 7, 2015	Class II	Z-1926-2015	Under Investigation by firm	Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only)…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 6 ancestors has a recall of any class.
Of its descendants, K060853 (Roche Diagnostics Corp., 2006) has gone furthest, with 0 descendants of its own.
31 other devices also cite its predicate K951595.

How does its category compare?

All JQB devices

JQB Kinetic Method, Gamma-Glutamyl Transpeptidase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQB

FDA has decided no JQB device since 2007.

Median 510(k) review, days · JQB

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

Recalls per year · JQB

No recall names JQB since 2007.

Adverse event reports per year · JQB

2in 2024

2007high 2 (2010) · low 0 (2007)2025

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

View these four charts as a table

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

What is it indicated for?

All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562). contains an in vitro diagnostic reagent system intended for use on COBAS…

Read the full statement (353 words)

All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer.

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562).

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD" oxidoreductase ) in serum and plasma (test LDHI, 0-181).

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid (tests TPU, 0-123 and TPC, 0-223).

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid (tests LACT, 0-22 and LACTC, 0-122).

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of tobramycin in serum or heparinized plasma (test TOBR, 0-92).

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin A in serum. In addition to the standard application (test IGA, 0-075), the sensitive application (test IGAP, 0-175) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples.

contains an in vitro diagnostic reagent system intended, for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin G in serum. In addition to the standard application (test IGG, 0-076), the sensitive application (test IGGP, 0-176) is designed for the quantitative determination of low IgG concentrations in e.g. pediatric samples.

contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin M in serum. In addition to the standard application (test IGM, 0-077), the sensitive application (test IGMP, 0-177) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples.

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/K964457 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964457: Roche Cobas Ibtegra Reagent Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964457

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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