# K062862: Olympus Uric Acid Reagent, Model OSR6X98

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Apr 6, 2007 after 193 days
- Product code: KNK (Acid, Uric, Uricase (Colorimetric))
- Device class: 1
- Regulation: 21 CFR 862.1775
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 24, 2018 · Class II · Z-0211-2020: NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
- Apr 13, 2016 · Class II · Z-1932-2016: Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93
- Dec 15, 2014 · Class II · Z-1024-2015: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6

## Indications for use
System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers 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/K062862
Methodology: https://510kreport.com/methodology