# K910593: Roche Reagent for Direct Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Apr 24, 1991 after 71 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060325: Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P (2006), 2 descendants of its own
- K171401: ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (2017), 0 descendants of its own
- K110780: Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & II (2011), 0 descendants of its own
- K050266: Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor (2005), 0 descendants of its own
- K991175: Modification to Alcyon Direct Bilirubin (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K910593
Methodology: https://510kreport.com/methodology