# K981943: DBIL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 22, 1998 after 49 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: 2 generations back to K912024 (1991). 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)
- K970985: Wako Total Bilirubin V, Wako Chemicals USA, Inc. (1997) Summary page 1.

## Indications for use
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum or plasma. Measurement 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/K981943
Methodology: https://510kreport.com/methodology