# K040467: Vitalab Uric Acid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Mar 8, 2004 after 13 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 Plus Reagent, product no. 1661850: named in the summary without a submission number

## Indications for use
The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used 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.

Source page: https://510kreport.com/device/K040467
Methodology: https://510kreport.com/methodology