# K152343: Direct Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Feb 16, 2016 after 181 days
- Product code: JFM (Enzymatic Method, 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
Longest line of descent: 3 generations back to K912024 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791, Wako Chemicals USA, Inc. (2005) Summary page 4.

## Indications for use
The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. Bilirubin measurements can be used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders including hepatitis and gall bladder block. This device is for prescription use only.

Source page: https://510kreport.com/device/K152343
Methodology: https://510kreport.com/methodology