Cleared Traditional

K923503 - URIC ACID ENZYMATIC COLORIMERIC KIT

K923503 is the FDA 510(k) clearance for URIC ACID ENZYMATIC COLORIMERIC KIT by Randox Laboratories, Ltd.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K923503 · Randox Laboratories, Ltd. · Chemistry device
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Jul 1993
Decision
372d
Days
Class 1
Risk

K923503 is an FDA 510(k) clearance for the URIC ACID ENZYMATIC COLORIMERIC KIT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on July 22, 1993 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K923503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date July 22, 1993
Days to Decision 372 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
284d slower than avg
Panel avg: 88d · This submission: 372d
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 78
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K923503.
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MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · Heraeus Kulzer, Inc. · Sep 1992