# K131544: Cobas C Bilirubin Total Gen.3

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 17, 2013 after 49 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K781921 (1979). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226, Roche Diagnostics Corp. (2006) Summary page 4.

## Most influential descendants
- K251998: Atellica CH Diazo Total Bilirubin (D_TBil) (2026), 0 descendants of its own

## Recalls of this device
- Sep 11, 2019 · Class III · Z-0153-2020: Due to low Quality Control recovery and invalid Calibration.
- Dec 17, 2018 · Class II · Z-1145-2019: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have 

## Indications for use
cobas c Bilirubin Total Gen.3 is an in vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. Measurement of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is 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/K131544
Methodology: https://510kreport.com/methodology