# K974874: Bilirubin-SL (Total) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd. (Usa)
- Decided: Feb 12, 1998 after 45 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 Total Bilirubin in serum. For IN VITRO diagnostic use. Bilirubin is a bile pigment normally found in serum as a result of red cell destruction. It 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. The elevation of total serum bilirubin may occur due to hemolytic processes, liver disease, or a disorder of the biliary tract. Traditional methods of measuring bilirubin are based on the reaction of bilirubin with a diazo reagent to form the colored compound: azo-bilirubin. The diazo reaction can be accelerated by the addition of various chemicals. For example, Malloy-Evelyn (1) used ethanol, Jendrassik-Grof (2) used caffeine, and Walters-Gerarde (3) used DMSO. Modifications of these methods included the addition of surfactants as solubilizing agents (4). In this method, a 2,4-dichlorophenyl diazonium salt is used as the diazo reagent and the reaction is facilitated by the use of a surfactant.

Source page: https://510kreport.com/device/K974874
Methodology: https://510kreport.com/methodology