# K060574: Total Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 3, 2006 after 58 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: 1 generation back to K910591 (1991). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910591: Roche Reagent for Total Bilirubin, Roche Diagnostic Systems, Inc. (1991) Summary page 5.

## Most influential descendants
- K121985: Architect Total Bilirubin (2013), 3 descendants of its own
- K150510: Total Bilirubin (2015), 1 descendant of its own
- K223324: Total Bilirubin2 (2022), 0 descendants of its own
- 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. 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/K060574
Methodology: https://510kreport.com/methodology