# K981766: Uric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 19, 1998 after 31 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). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873363: Uric Acid Pap, Boehringer Mannheim Corp. (1987) Summary page 2.

## Most influential descendants
- K102568: Uric Acid Model 3P39 (2011), 0 descendants of its own

## Indications for use
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. 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/K981766
Methodology: https://510kreport.com/methodology