Cleared Traditional

URIC ACID REAGENT SET (K914158) - FDA 510(k) Clearance

Class I Chemistry device.

K914158 · Tech Intl. Co. · Chemistry device
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Feb 1992
Decision
157d
Days
Class 1
Risk

K914158 is an FDA 510(k) clearance for the URIC ACID REAGENT SET. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 21, 1992 after a review of 157 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 Tech Intl. Co. devices

Submission Details

510(k) Number K914158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1991
Decision Date February 21, 1992
Days to Decision 157 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
69d slower than avg
Panel avg: 88d · This submission: 157d
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 117
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K914158.
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K931350 · Instrumentation Laboratory CO · Oct 1993
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K922762 · Roche Diagnostic Systems, Inc. · Jul 1992
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · Em Diagnostic Systems, Inc. · Sep 1991