# K080435: Olympus Direct Bilirubin Reagent, Model OSR6X181

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Life Science Research Europa GmbH (Europa)
- Decided: Sep 5, 2008 after 199 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers. Measurements 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/K080435
Methodology: https://510kreport.com/methodology