# K981609: Bilirubin-SL (Direct) Assay Catalogue Number 247-10,247-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jun 3, 1998 after 29 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
For the quantitative determination of in Bilirubin (Direct) in serum. For IN VITRO diagnostic use. Bilirubin is a product of hemoglobin breakdown by the reticuloendothelial system and exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it becomes conjugated (direct) with glucuronic acid and excreted. Elevated serum bilirubin is indicative of impairment of the liver, excessive hemolysis, or obstruction of the biliary tract. Bilirubin determination is generally based on the reaction of bilirubin with diazotized sulfanilic acid, as described by Ehrlich (1). In this method, direct (conjugated) bilirubin couples with a diazonium salt in the presence of sulfamic acid to form the colored compound, azo-bilirubin.

Source page: https://510kreport.com/device/K981609
Methodology: https://510kreport.com/methodology