510(k) Report

510(k) · Cleared

Cleared

Cobas Integra C 111

K063744510(k) SpecialCleared Jan 17, 200730-day reviewClass II21 CFR 862.1110

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

Rochdiag · CIG Diazo Colorimetry, Bilirubin

Cleared on Jan 17, 2007 as substantially equivalent to K063543 (Roche Diagnostics Corp., 2006) after a 30-day review. Its family tree reaches back 3 generations to 1979. 6 later devices descend from it.

Decided
Jan 17, 2007
Review
30 days
Class
Class II
Product code
CIG
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K781921 (1979). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2012: 2 descendants cleared2011: 2 descendants cleared2007: 1 descendant cleared2014: 1 descendant clearedReference device: K951595 · Roche Cobas Integra Analyzer, Reagent Cassettes · Roche Diagnostic Systems, Inc. · 1995 · recalledK781921 · Bilirubin, Dingle Valve DPD · Boehringer Mannheim Corp. · 1979K981632 · Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent · Roche Diagnostics/Boehringer Mannheim GmbH · 1998K063543 · Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226 · Roche Diagnostics Corp. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants K063543 · Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226 · Roche Diagnostics Corp. · 2006K981632 · Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent · Roche Diagnostics/Boehringer Mannheim GmbH · 1998K781921 · Bilirubin, Dingle Valve DPD · Boehringer Mannheim Corp. · 19790
  1. Root · 3 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
  2. 2 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
  3. 1 generation backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
  4. This deviceK063744 Cobas Integra C 111Rochdiag · 2007
  5. Descendant · cites it directly · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
  6. Descendant · cites it directly · 1 of its ownK071211 Cobas C 111 AnalyzerRoche Diagnostics · 2007 · Recalled
  7. Descendant · 2 generations on · 0 of its ownK141265 Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014
  8. Descendant · cites it directly · 0 of its ownK122858 Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2…Elitechgroup · 2012
  9. Descendant · cites it directly · 0 of its ownK110830 Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems…Elitechgroup · 2011 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12011: 22012: 22014: 1
2007high 2 (2011) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · cites it directly1descendant
  • K071211Cobas C 111 AnalyzerRoche Diagnostics · 2007 · cites it directly1descendant
  • K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014 · 2 generations on0descendants
  • K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup · 2012 · cites it directly0descendants
  • K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K781921Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp.1979—
−2K981632Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH1998—
−1K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models…Roche Diagnostics Corp.2006—
0 (this device)K063744Cobas Integra C 111Rochdiag2007—
+1K122083Elitech Clinical Systems CK Nac SLElitechgroup2012—
+1K071211Cobas C 111 AnalyzerRoche Diagnostics20073
+2K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup2014—
+1K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech…Elitechgroup2012—
+1K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin…Elitechgroup20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201120
201220
201410
FIG. 1 — Lineage of K063744, 1979–2014Source: 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), 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 CIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CIG device

  1. #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322…
Cleared while this submission was under review
Summary page 1
…for use as: * COBAS INTEGRA Total Bilirubin Special K981632/AOO1 * And modified as COBAS INTEGRA Total Bilirubin Special K063543 Modifications to the test systems include: * Reagcnt application to the cobas c I ll…
Roche Diagnostics Corp.2006—
†K951595Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc.19957

Also cleared against K063543: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K122083Elitech Clinical Systems CK Nac SLElitechgroup20121
K071211Cobas C 111 AnalyzerRoche Diagnostics20071
K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120
K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup20110

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?

  • The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K122083 (Elitechgroup, 2012) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K063543.

How does its category compare?

All CIG devices

CIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · CIG

2in 2023

2007: 12008: 32009: 22010: 12011: 22013: 52015: 12017: 12019: 12022: 12023: 22026 (partial year): 1
2007high 5 (2013) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIG

64in 2013

2008: 199 days median2013: 64 days median
2007high 199 (2008) · low 64 (2013)2026

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

Recalls per year · CIG

1in 2019

2009: 32013: 32019: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CIG

52in 2025

2007: 22008: 82009: 32010: 62011: 382012: 142013: 82014: 32015: 72016: 42017: 112018: 232019: 252020: 312021: 222022: 262023: 342024: 392025: 52
2007high 52 (2025) · low 2 (2007)2025

MAUDE reports naming product code CIG, 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
20071—02
2008319908
20092—33
20101—06
20112—038
20120—014
201356438
20140—03
20151—07
20160—04
20171—011
20180—023
20191—125
20200—031
20210—022
20221—026
20232—034
20240—039
20250—052
20261—0—

What is it indicated for?

In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system.

Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.

Indications for use as stated in the FDA summary.

Also cleared against K063543

2 other devices cite the same predicate.

  • K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics · 20132 recalls
  • K123965Cobas Integra Bilirubin Direct Gen.2Roche Diagnostics · 2013

More from Rochdiag

3 FDA decisions under this applicant name. See the company

  • K011658Calibrator for Automated Systems (C.F.a.S.) LipidsRochdiag · 2001
  • K010978Tina-Quant Alpha-1 AntitrypsinRochdiag · 2001

Recent decisions in CIG

The CIG category page

  • K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026
  • K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K223324Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
  • K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc. · 20193 recalls

https://510kreport.com/device/K063744 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063744: Cobas Integra C 111.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063744

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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