Cleared Traditional

K062862 - OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (FDA 510(k) Clearance)

Class I Chemistry device.

K062862 · Olympus America, Inc. · Chemistry device
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Apr 2007
Decision
193d
Days
Class 1
Risk

K062862 is an FDA 510(k) clearance for the OLYMPUS URIC ACID REAGENT, MODEL OSR6X98. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on April 6, 2007 after a review of 193 days - an extended review 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: 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 America, Inc. devices

Submission Details

510(k) Number K062862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date April 06, 2007
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
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.