# K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics/Boehringer Mannheim GmbH
- Decided: Jun 15, 1998 after 38 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
Longest line of descent: 1 generation back to K781921 (1979). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781921: Bilirubin, Dingle Valve DPD, Boehringer Mannheim Corp. (1979) Summary page 4.

## Most influential descendants
- K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226 (2006), 10 descendants of its own
- K063744: Cobas Integra C 111 (2007), 6 descendants of its own
- K131544: Cobas C Bilirubin Total Gen.3 (2013), 1 descendant of its own
- K122083: Elitech Clinical Systems CK Nac SL (2012), 1 descendant of its own
- K071211: Cobas C 111 Analyzer (2007), 1 descendant of its own

## Indications for use
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Source page: https://510kreport.com/device/K981632
Methodology: https://510kreport.com/methodology