# K983304: Synermed Near-Infrared Direct Bilirubin Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Synermed Intl., Inc.
- Decided: Nov 4, 1998 after 44 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® Direct Bilirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma. Bilirubin is a product of the catabolism of hemoglobin. Bilirubin is transported through the blood (bound to albumin) to the liver where it is conjugated with glucuronic acid to form the diglucuronide. The bilirubin, in its water soluble conjugated glucuronide form, enters the biliary system for excretion in the bile. Healthy subjects have virtually no detectable conjugated bilirubin. Elevated levels of serum conjugated bilirubin are observed in a variety of conditions including hepatocellular disease, biliary tract obstruction, and some conditions involved in bilirubin metabolism.

Source page: https://510kreport.com/device/K983304
Methodology: https://510kreport.com/methodology