# K031044: Atac Pak Uric Acid Reagent and Atac Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Jul 15, 2003 after 105 days
- Product code: KNK (Acid, Uric, Uricase (Colorimetric))
- Device class: 1
- Regulation: 21 CFR 862.1775
- 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 Uric Acid Reagent Kit, product no. 908241: named in the summary without a submission number
- (no number) C.f.a.s. Calibrator, product no. 759350: named in the summary without a submission number

## Indications for use
The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. 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/K031044
Methodology: https://510kreport.com/methodology