# K993771: Careside Direct Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Dec 27, 1999 after 49 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 K870365 (1987). 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)
- K870365: Direct Bilirubin Reagent - Acid Diazo Method, Trace Scientific, Ltd. (1987) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure direct bilirubin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with hepatic, hemolytic hematologic, and metabolic diseases, including hepatitis and gall bladder blockage.

Source page: https://510kreport.com/device/K993771
Methodology: https://510kreport.com/methodology