510(k) Report

510(k) · Cleared

Cleared

Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226

K063543510(k) SpecialCleared Dec 22, 200628-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

Roche Diagnostics Corp. · CIG Diazo Colorimetry, Bilirubin

Cleared on Dec 22, 2006 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1979. 10 later devices descend from it.

Decided
Dec 22, 2006
Review
28 days
Class
Class II
Product code
CIG
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K781921 (1979). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2007: 2 descendants cleared2013: 2 descendants cleared2012: 2 descendants cleared2011: 2 descendants cleared2026: 1 descendant cleared2014: 1 descendant clearedK781921 · Bilirubin, Dingle Valve DPD · Boehringer Mannheim Corp. · 1979K981632 · Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent · Roche Diagnostics/Boehringer Mannheim GmbH · 199819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K981632 · Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent · Roche Diagnostics/Boehringer Mannheim GmbH · 1998K781921 · Bilirubin, Dingle Valve DPD · Boehringer Mannheim Corp. · 19790
  1. Root · 2 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
  2. 1 generation backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
  3. This deviceK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
  4. Descendant · cites it directly · 6 of its ownK063744 Cobas Integra C 111Rochdiag · 2007
  5. Descendant · cites it directly · 1 of its ownK131544 Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
  7. Descendant · 2 generations on · 1 of its ownK071211 Cobas C 111 AnalyzerRoche Diagnostics · 2007 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK251998 Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007: 22011: 22012: 22013: 22014: 12026: 1
2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K063744Cobas Integra C 111Rochdiag · 2007 · cites it directly6descendants
  • K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · cites it directly1descendant
  • K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · 2 generations on1descendant
  • K071211Cobas C 111 AnalyzerRoche Diagnostics · 2007 · 2 generations on1descendant
  • K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K781921Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp.1979—
−1K981632Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH1998—
0 (this device)K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models…Roche Diagnostics Corp.2006—
+1K063744Cobas Integra C 111Rochdiag2007—
+1K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics20132
+2K122083Elitech Clinical Systems CK Nac SLElitechgroup2012—
+2K071211Cobas C 111 AnalyzerRoche Diagnostics20073
+2K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201120
201220
201320
201410
202610
FIG. 1 — Lineage of K063543, 1979–2026Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K951595Roche Cobas Integra Analyzer, Reagent Cassettes
Summary page 1
…r Bilirubin (Total and Direct) test systems. The reagents were originally cleared for use as: COBAS INTEGRA Bilirubin Direct K95 1595 COBAS INTEGRA Total Bilirubin Special K981632/A00l Roche/Hitachi Total Bilirubin K981632/A0O1…
Roche Diagnostic Systems, Inc.19957
*K981632Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent
Summary page 1
…e reagents were originally cleared for use as: COBAS INTEGRA Bilirubin Direct K95 1595 COBAS INTEGRA Total Bilirubin Special K981632/A00l Roche/Hitachi Total Bilirubin K981632/A0O1 Note that COBAS INTEGRA Total Bilirubin Special an…
Roche Diagnostics/Boehringer Mannheim GmbH1998—

Also cleared against K951595: 31 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K063744Cobas Integra C 111Rochdiag20076
K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics20131
K123965Cobas Integra Bilirubin Direct Gen.2Roche Diagnostics20130

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 27 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K063744 (Rochdiag, 2007) has gone furthest, with 6 descendants of its own.
  • 31 other devices also cite its predicate K951595.

How does its category compare?

All CIG devices

CIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

COBAS INTEGRA Bilirubin Direct The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049). COBAS INTEGRA Total Bilirubin Special The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for…

Read the full statement (150 words)

COBAS INTEGRA Bilirubin Direct

The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049).

COBAS INTEGRA Total Bilirubin Special

The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates (test BILTS, 0-985).

Roche Hitachi Total Bilirubin Special

For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers.

Measurement of the levels of bilirubin and organic compound formed during the normal and abnormal distruction of red cells, if used in the diagnosis of liver, hemolytic hemoatological, and metabolic disorders, including hepatitis and gall bladder block

Indications for use as stated in the FDA summary.

Also cleared against K951595

31 other devices cite the same predicate.

  • K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL…Elitechgroup · 2016
  • K160570Creatine KinaseRoche Diagnostics Operations (Rdo) · 20161 recall
  • K081193Cobas Integra 400/800 Bilirubin TotalRoche Diagnostics · 2009
  • K071644Online Phenobarbital, Model 03016757190 & 03510620Roche Diagnostics Corp. · 2007
  • K060773Online TDM ProcainamideRoche Diagnostics Corp. · 2006
  • K060738TDM N-AcetylprocainamideRoche Diagnostics Corp. · 20061 recall

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

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/K063543 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063543

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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