# K011972: Direct Bilirubin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Intersect Systems, Inc.
- Decided: Aug 27, 2001 after 63 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A bilirubin test system is an in vitro device intended to measure direct bilirubin quantitatively in serum or plasma. Bilirubin is an organic compound formed during the normal and abnormal distruction of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.

Source page: https://510kreport.com/device/K011972
Methodology: https://510kreport.com/methodology