Cleared Traditional

OLYMPUS URIC ACID REAGENT (K925113) - FDA 510(k) Clearance

Class I Chemistry device.

K925113 · Olympus Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
109d
Days
Class 1
Risk

K925113 is an FDA 510(k) clearance for the OLYMPUS URIC ACID REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Corp. devices

Submission Details

510(k) Number K925113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1992
Decision Date January 26, 1993
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KNK Acid, Uric, Uricase (colorimetric)

All 39
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K925113.
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919 · Beckman Instruments, Inc. · May 1997
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · Eastman Kodak Company · Apr 1994
IL TEST URIC ACID
K931350 · Instrumentation Laboratory CO · Oct 1993
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS URIC ACID REAGENT
K922756 · Olympus Corp. · Jul 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc. · Jul 1992