# K223324: Total Bilirubin2

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Ireland Diagnostics Division
- Decided: Dec 29, 2022 after 59 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.
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)
- K121985: Architect Total Bilirubin, Abbott Laboratories (2013) Summary page 5.

## Indications for use
The Total Bilirubin2 assay is used for the quantitation of total bilirubin in human serum or plasma, of adults and neonates, on the ARCHITECT c 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 disorders of the biliary tract. In newborn infants, the Total Bilirubin2 assay is intended to measure the levels of total bilirubin (conjugated and unconjugated) in serum or plasma to aid in the diagnosis and management of neonatal jaundice and hemolytic disease of the newborn.

Source page: https://510kreport.com/device/K223324
Methodology: https://510kreport.com/methodology