# K981336: TBIL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 1, 1998 after 18 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurements of the levels of 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.

Source page: https://510kreport.com/device/K981336
Methodology: https://510kreport.com/methodology