# K972716: Synermed Total Bilirubin Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Synermed, Inc.
- Decided: Aug 7, 1997 after 17 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
The Synermed® Total Bilirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only. Elevated serum bilirubin levels are observed in a variety of conditions including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis and decreased conjugation (e.g. neonatal jaundice).

Source page: https://510kreport.com/device/K972716
Methodology: https://510kreport.com/methodology