# K063744: Cobas Integra C 111

- Pathway: 510(k) (Special)
- Applicant: Rochdiag
- Decided: Jan 17, 2007 after 30 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: 3 generations back to K781921 (1979). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 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). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K122083: Elitech Clinical Systems CK Nac SL (2012), 1 descendant of its own
- K071211: Cobas C 111 Analyzer (2007), 1 descendant of its own
- K141265: Elitech Clinical Systems Envoy 500 CK Reagent Kit (2014), 0 descendants of its own
- K122858: Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical Systems Elitrol I and Elitrol II (2012), 0 descendants of its own
- K110830: Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech (2011), 0 descendants of its own

## Indications for use
In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system. Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.

Source page: https://510kreport.com/device/K063744
Methodology: https://510kreport.com/methodology