# K023330: Bilirubin-SL (Total) Assay, Model 284-10/30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Dec 11, 2002 after 68 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. The FDA summary names no predicate by number.

## Indications for 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 hemolyhc processes, liver disease, or a disorder of the biliary tract. For the quantitative determination of Bilirubin (Total) in serum. For IN VITRO diagnostic use.

Source page: https://510kreport.com/device/K023330
Methodology: https://510kreport.com/methodology