510(k) · Cleared
ClearedTotal Bilirubin L3K, Model 295-10 and 295-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Diagnostics P.E.I., Inc. · CIG Diazo Colorimetry, Bilirubin
Cleared on Dec 16, 2008 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 16, 2008
- Review
- 132 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.
Measurement of Total Bilirubin is used in the diagnosis and management of liver disease,
biliary tract obstruction, various hemolytic diseases and disorders involving the
metabolism of bilirubin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082210 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082210: Total Bilirubin L3K, Model 295-10 and 295-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082210
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026