Cleared Traditional

K922756 - OLYMPUS URIC ACID REAGENT

K922756 is the FDA 510(k) clearance for OLYMPUS URIC ACID REAGENT by Olympus Corp.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K922756 · Olympus Corp. · Chemistry device

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Jul 1992

Decision

38d

Days

Class 1

Risk

K922756 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 July 17, 1992 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Corp. devices

Submission Details

510(k) Number	K922756 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 09, 1992
Decision Date	July 17, 1992
Days to Decision	38 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

50d faster than avg

Panel avg: 88d · This submission: 38d

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 82

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K922756.

OLYMPUS URIC ACID REAGENT

K925113 · Olympus Corp. · Jan 1993

SYNERMED 600 NM URIC ACID REAGENT KIT

K923414 · Synermed, Inc. · Sep 1992

MILES AUTO METH DETERMIN OF URIC ACID IN URINE

K924129 · Heraeus Kulzer, Inc. · Sep 1992

ROCHE REAGENT FOR URIC ACID--MODIFICATION

K922762 · Roche Diagnostic Systems, Inc. · Jul 1992

ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34

K913706 · Em Diagnostic Systems, Inc. · Sep 1991

SYNERMED URIC ACID REAGENT KIT

K903727 · Synermed, Inc. · Sep 1990

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K922756

Olympus Corp.

Lake Success, NY · US

LAURA STORMS-TYLER

Regulatory profile

142 submissions 140 cleared

99% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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