# K040631: Vitalab Direct Bilirubin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Mar 18, 2004 after 8 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) Roche Direct Bilirubin Reagent, product no. 0737499: named in the summary without a submission number
- (no number) Beckman Total Bilirubin Reagent, product no. 442745: named in the summary without a submission number
- (no number) Beckman Bilirubin Calibrator, product no. 465915: named in the summary without a submission number

## Indications for use
The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. The Vitalab Bilirubin Calibrator is intended for use with the Vitalab Selectra Analyzer to establish points of reference that are used in the determination of total and direct bilirubin in human specimens.

Source page: https://510kreport.com/device/K040631
Methodology: https://510kreport.com/methodology