Cleared Traditional

K931350 - IL TEST URIC ACID

K931350 is the FDA 510(k) clearance for IL TEST URIC ACID by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K931350 · Instrumentation Laboratory CO · Chemistry device
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Oct 1993
Decision
198d
Days
Class 1
Risk

K931350 is an FDA 510(k) clearance for the IL TEST URIC ACID. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 198 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.

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Submission Details

510(k) Number K931350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date October 01, 1993
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 88d · This submission: 198d
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 61
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K931350.
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586 · Diagnostic Chemicals , Ltd. · Jul 1996
URIC ACID CATALOGE# 220-93/94/97
K955496 · Diagnostic Chemicals , Ltd. · Feb 1996
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · Eastman Kodak Company · Apr 1994
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503 · Randox Laboratories, Ltd. · Jul 1993
OLYMPUS URIC ACID REAGENT
K925113 · Olympus Corp. · Jan 1993
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · Heraeus Kulzer, Inc. · Sep 1992