# K971485: Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: May 27, 1997 after 34 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), 2 descendants of its own
- K183375: Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (2019), 0 descendants of its own
- K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents (2011), 0 descendants of its own
- K992798: Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (1999), 0 descendants of its own
- K982251: Sigma Diagnostics Infinity Uric Acid Reagent Kit (1998), 0 descendants of its own

## Indications for use
intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis. This Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this 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, CFR 862.1775

Source page: https://510kreport.com/device/K971485
Methodology: https://510kreport.com/methodology