# K111143: Poly-Chem 90 Total Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: Sep 1, 2011 after 132 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 K973995 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973995: Randox Bilirubin, Randox Laboratories, Ltd. (1997) Summary page 1.

## Indications for use
Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level 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 hemnatological, and metabolic disorders, including hepatitis and gall bladder block.

Source page: https://510kreport.com/device/K111143
Methodology: https://510kreport.com/methodology