# K982251: Sigma Diagnostics Infinity Uric Acid Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Aug 18, 1998 after 53 days
- Product code: CDO (Acid, Uric, Uricase (U.V.))
- 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
Longest line of descent: 1 generation back to K971485 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971485: Uric Acid - Incorporating Dynamic Stabilization Technology - (DST), Trace America, Inc. (1997) Summary page 1.

## Indications for use
The Sigma Diagnostics INFINITY ™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the device are used in 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/K982251
Methodology: https://510kreport.com/methodology