# K024116: Wiener Lab. Bilirubina Direct AA

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Feb 12, 2003 after 61 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.
No later device cites it as a predicate yet.
0 of 1 device 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) DMA Direct Bilirubin Plus test system: named in the summary without a submission number

## Indications for use
The "Wiener lab. Bilirrubina directa AA" test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, are 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/K024116
Methodology: https://510kreport.com/methodology