# K022180: Direct Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 6, 2002 after 65 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Direct Bilirubin assay on the Hitachi 717 Analyzer: named in the summary without a submission number

## Most influential descendants
- K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (2021), 1 descendant of its own
- K251157: Core Metabolic (2026), 0 descendants of its own

## Indications for use
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma. Measurement of direct 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/K022180
Methodology: https://510kreport.com/methodology