# K981588: Careside Total Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Jun 23, 1998 after 50 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 K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 2.

## Indications for use
This product is for in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure total bilirubin concentration in anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder blockage. It is intended for professional laboratory use: not for point of care use or physician office laboratory use.

Source page: https://510kreport.com/device/K981588
Methodology: https://510kreport.com/methodology