# K981189: Uric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 7, 1998 after 35 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 K873363 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922762: Roche Reagent for Uric Acid--Modification, Roche Diagnostic Systems, Inc. (1992) Summary page 2.
- K873363: Uric Acid Pap, Boehringer Mannheim Corp. (1987) Summary page 2.

## Indications for use
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. Measurements of uric acid 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/K981189
Methodology: https://510kreport.com/methodology