# K030014: Atac Total Bilirubin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Elan Diagnostics
- Decided: Sep 26, 2003 after 267 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) Beckman Synchron Total Bilirubin Reagent, product 442745: named in the summary without a submission number

## Indications for use
The ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K030014
Methodology: https://510kreport.com/methodology