510(k) · Cleared
ClearedRoche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics/Boehringer Mannheim GmbH · CIG Diazo Colorimetry, Bilirubin
Cleared on Jun 15, 1998 as substantially equivalent to K781921 (Boehringer Mannheim Corp., 1979) after a 38-day review. Its family tree reaches back 1 generation to 1979. 12 later devices descend from it.
- Decided
- Jun 15, 1998
- Review
- 38 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781921 (1979). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- This deviceK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- Descendant · cites it directly · 10 of its ownK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 6 of its ownK063744 Cobas Integra C 111Rochdiag · 2007
- Descendant · 2 generations on · 1 of its ownK131544 Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
- Descendant · 3 generations on · 1 of its ownK071211 Cobas C 111 AnalyzerRoche Diagnostics · 2007 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322…Roche Diagnostics Corp. · 2006 · cites it directly10descendants
- K063744Cobas Integra C 111Rochdiag · 2007 · 2 generations on6descendants
- K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · 2 generations on1descendant
- K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · 3 generations on1descendant
- K071211Cobas C 111 AnalyzerRoche Diagnostics · 2007 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| 0 (this device) | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| +1 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| +2 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| +2 | K131544 | Cobas C Bilirubin Total Gen.3 | Roche Diagnostics | 2013 | 2 |
| +3 | K122083 | Elitech Clinical Systems CK Nac SL | Elitechgroup | 2012 | — |
| +3 | K071211 | Cobas C 111 Analyzer | Roche Diagnostics | 2007 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2026 | 1 | 0 |
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 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K781921 | Bilirubin, Dingle Valve DPDSummary page 4…Roche Diagnostics, Boehringer Mannheim Total Bilirubin/DPD reagent system, catalog number 1039034, a modification of the Single Vial DPD Total Bilirubin reagent system, K781921. Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (p… | 1979 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K063543 (Roche Diagnostics Corp., 2006) has gone furthest, with 10 descendants of its own.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in…
Read the full statement (115 words)
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates.
It is for use on automated clinical chemistry analyzers.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
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/K981632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981632
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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