# K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 22, 2006 after 28 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: 2 generations back to K781921 (1979). 3 ancestors in all.
10 later devices descend from it; 3 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)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.
- K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent, Roche Diagnostics/Boehringer Mannheim GmbH (1998) Summary page 1.

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

## Indications for use
COBAS INTEGRA Bilirubin Direct The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049). COBAS INTEGRA Total Bilirubin Special The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates (test BILTS, 0-985). Roche Hitachi Total Bilirubin Special For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers. Measurement of the levels of bilirubin and organic compound formed during the normal and abnormal distruction of red cells, if used in the diagnosis of liver, hemolytic hemoatological, and metabolic disorders, including hepatitis and gall bladder block

Source page: https://510kreport.com/device/K063543
Methodology: https://510kreport.com/methodology