# K981604: Careside Uric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Jun 25, 1998 after 58 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
Longest line of descent: 1 generation back to K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure uric acid from whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with numerous renal and metabolic disorders including renal failure, gout, leukemia, psoriasis, starvation or wasting conditions, and of patients receiving cytotoxic drugs. It is intended for professional laboratory use: not for point of care or physician office laboratory use.

Source page: https://510kreport.com/device/K981604
Methodology: https://510kreport.com/methodology