510(k) · Cleared
ClearedRoche Reagent for Total Bilirubin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · CIG Diazo Colorimetry, Bilirubin
Cleared on Apr 24, 1991 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Apr 24, 1991
- Review
- 71 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK910591 Roche Reagent for Total BilirubinRoche Diagnostic Systems, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK060574 Total BilirubinAbbott Laboratories · 2006
- Descendant · 2 generations on · 3 of its ownK121985 Architect Total BilirubinAbbott Laboratories · 2013
- Descendant · cites it directly · 2 of its ownK060325 Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx…Horiba Abx · 2006
- Descendant · 3 generations on · 1 of its ownK150510 Total BilirubinAbbott Laboratories · 2015
- Descendant · 3 generations on · 0 of its ownK223324 Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060574Total BilirubinAbbott Laboratories · 2006 · cites it directly4descendants
- K121985Architect Total BilirubinAbbott Laboratories · 2013 · 2 generations on3descendants
- K060325Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…Horiba Abx · 2006 · cites it directly2descendants
- K150510Total BilirubinAbbott Laboratories · 2015 · 3 generations on1descendant
- K223324Total Bilirubin2Abbott Ireland Diagnostics Division · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910591 | Roche Reagent for Total Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| +1 | K060574 | Total Bilirubin | Abbott Laboratories | 2006 | — |
| +2 | K121985 | Architect Total Bilirubin | Abbott Laboratories | 2013 | — |
| +1 | K060325 | Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra… | Horiba Abx | 2006 | — |
| +3 | K150510 | Total Bilirubin | Abbott Laboratories | 2015 | — |
| +3 | K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 115 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?
- Of its descendants, K060574 (Abbott Laboratories, 2006) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K910591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910591: Roche Reagent for Total Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910591
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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