# K973995: Randox Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Dec 8, 1997 after 48 days
- Product code: GIG (Hemoglobinometer)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K111143: Poly-Chem 90 Total Bilirubin (2011), 0 descendants of its own

## Indications for use
The Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent for the quantitative determination of total and direct bilirubin in human serum and plasma. This method uses diazotized sulphanilic acid to measure bilirubin. To measure total bilirubin the sample is first incubated with caffeine which releases bilirubin from albumin. Direct (conjugate) bilirubin is determined in the absence of caffeine. Measurements of bilirubin are used in the diagnosis of liver disease, in the detection of haemolytic anaemia and to evaluate jaundice. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K973995
Methodology: https://510kreport.com/methodology