510(k) · Cleared
ClearedRoche Reagent for Direct 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. 6 later devices descend from it.
- Decided
- Apr 24, 1991
- Review
- 71 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK910593 Roche Reagent for Direct BilirubinRoche Diagnostic Systems, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK060325 Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx…Horiba Abx · 2006
- Descendant · 2 generations on · 0 of its ownK171401 ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical…Elitechgroup · 2017
- Descendant · 2 generations on · 0 of its ownK110780 Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical…Elitechgroup · 2011
- Descendant · cites it directly · 0 of its ownK050266 Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory · 2005
- Descendant · cites it directly · 0 of its ownK991175 Modification to Alcyon Direct BilirubinAbbott Laboratories · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060325Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…Horiba Abx · 2006 · cites it directly2descendants
- K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…Elitechgroup · 2017 · 2 generations on0descendants
- K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup · 2011 · 2 generations on0descendants
- K050266Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory · 2005 · cites it directly0descendants
- K991175Modification to Alcyon Direct BilirubinAbbott Laboratories · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910593 | Roche Reagent for Direct Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| +1 | K060325 | Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra… | Horiba Abx | 2006 | — |
| +2 | K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems… | Elitechgroup | 2017 | — |
| +2 | K110780 | Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical… | Elitechgroup | 2011 | — |
| +1 | K050266 | Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor | Stanbio Laboratory | 2005 | — |
| +1 | K991175 | Modification to Alcyon Direct Bilirubin | Abbott Laboratories | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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? (6)
4 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, K060325 (Horiba Abx, 2006) has gone furthest, with 2 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/K910593 · printed Nov 3, 2026
Cite this page
510(k) Report. “K910593: Roche Reagent for Direct Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910593
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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