# CIG: Diazo Colorimetry, Bilirubin

- Device class: 2; regulation: 21 CFR 862.1110; FDA's rule: 510(k) required
- FDA decisions: 235
- 510(k) review time 2021–2025: median 245 days (middle half 152–250)
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 2
- 2010: 1
- 2011: 2
- 2013: 5
- 2015: 1
- 2017: 1
- 2019: 1
- 2022: 1
- 2023: 2
- 2026: 1

## Most-cited predicates
- K910591: Roche Reagent for Total Bilirubin (1991), cited by 5
- K910593: Roche Reagent for Direct Bilirubin (1991), cited by 4
- K063744: Cobas Integra C 111 (2007), cited by 4
- K050869: Modification to ABL800 Flex (2005), cited by 4
- K862359: Meth./Cali./Intru. Check for the Dimension System (1986), cited by 4
- K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226 (2006), cited by 3
- K840880: Ektachem Clinical Chem. Slides (1984), cited by 3
- K970986: Wako Direct Bilirubin V (1997), cited by 2
- K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to (2010), cited by 2
- K060325: Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P (2006), cited by 2

Source page: https://510kreport.com/product-code/CIG
Data by year (CSV): https://510kreport.com/product-code/CIG.csv