# K150510: Total Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 2, 2015 after 34 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
Longest line of descent: 3 generations back to K910591 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121985: Architect Total Bilirubin, Abbott Laboratories (2013) Summary page 4.

## Most influential descendants
- K170065: ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) (2017), 0 descendants of its own

## Indications for use
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT ¢8000 System. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Source page: https://510kreport.com/device/K150510
Methodology: https://510kreport.com/methodology