# K152344: Total Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Jan 28, 2016 after 162 days
- Product code: JFM (Enzymatic Method, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992399 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063845: Advia Chemistry Total Bilirubin_2, Bayer Healthcare, LLC (2007) Summary page 5.

## Recalls of this device
- Oct 11, 2023 · Class II · Z-0501-2024: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

## Indications for use
For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K152344
Methodology: https://510kreport.com/methodology