510(k) Report

510(k) · Cleared

Cleared

Roche Cobas Integra Reagent Cassettes

K954992510(k) TraditionalCleared Jan 25, 199686-day reviewClass II21 CFR 862.1100

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. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Jan 25, 1996 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided
Jan 25, 1996
Review
86 days
Class
Class II
Product code
CIT
Recalls
None
Predicates
0

21 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 3 descendants cleared2004: 1 descendant cleared1998: 1 descendant cleared2006: 4 descendants cleared2016: 1 descendant cleared2003: 3 descendants cleared2001: 1 descendant cleared2011: 3 descendants cleared2019: 1 descendant cleared2007: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954992 Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1996
  2. Descendant · cites it directly · 9 of its ownK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
  3. Descendant · 2 generations on · 8 of its ownK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
  4. Descendant · 3 generations on · 2 of its ownK032377 Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003
  5. Descendant · 3 generations on · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
  6. Descendant · 3 generations on · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 32001: 12003: 32004: 12006: 42007: 12011: 32016: 12019: 12023: 1
1997high 4 (2006) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all
  • K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc. · 1998 · cites it directly9descendants
  • K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003 · 2 generations on8descendants
  • K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003 · 3 generations on2descendants
  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · 3 generations on1descendant
  • K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954992Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc.1996—
+1K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc.1998—
+2K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp.2003—
+3K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp.2003—
+3K183555GEM Premier ChemSTATInstrumentation Laboratory CO2019—
+3K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20062

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199930
200110
200330
200410
200640
200710
201130
201610
201910
202310
FIG. 1 — Lineage of K954992, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in CIT? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc.19989
K060586Enzyme Immunoassay, VancomycinRoche Diagnostics Corp.20061
K991598Cobas Integra AcetaminophenRoche Diagnostics Corp.19991
K991597Cobas Integra Amikacin MabRoche Diagnostics Corp.19991
K990594Integra Reagent Cassette for Apolipoprotein a-1Roche Diagnostics Corp.19991
K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.19971
K032334Roche Online TDM LidocaineRoche Diagnostics Corp.20040

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?

  • Of its descendants, K980996 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 9 descendants of its own.

How does its category compare?

All CIT devices

CIT Nadh Oxidation/Nad Reduction, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIT

1in 2010

2007: 22008: 22010: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIT

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

Recalls per year · CIT

1in 2023

2008: 32012: 12013: 12014: 12023: 1
2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · CIT

10in 2025

2007: 232008: 172010: 12011: 72012: 22015: 12017: 22018: 12019: 22020: 12021: 52022: 22023: 22024: 82025: 10
2007high 23 (2007) · low 0 (2009)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—023
20082—317
20090—00
20101—01
20110—07
20120—12
20130—10
20140—10
20150—01
20160—00
20170—02
20180—01
20190—02
20200—01
20210—05
20220—02
20230—12
20240—08
20250—010
20260—0—

More from Roche Diagnostic Systems, Inc.

296 FDA decisions under this applicant name. See the company

  • K983698Modification to Abuscreen Online BarbituratesRoche Diagnostic Systems, Inc. · 1999
  • K983702Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
  • K983704Modification to Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1999
  • K983556Abuscreen Online Benz 300 CalibratorsRoche Diagnostic Systems, Inc. · 1998
  • K983555Abuscreen Online Benz 200 CalibratorsRoche Diagnostic Systems, Inc. · 1998

Recent decisions in CIT

The CIT category page

  • K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580…Seppim S.A.S. · 2010
  • K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH · 2008
  • K071525Activated Aspartate AminotransferaseAbbott Laboratories · 20081 recall
  • K071580Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY · 2007
  • K071211Cobas C 111 AnalyzerRoche Diagnostics · 20073 recalls

https://510kreport.com/device/K954992 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954992: Roche Cobas Integra Reagent Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954992

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026