Cleared Traditional

K923503 - URIC ACID ENZYMATIC COLORIMERIC KIT

K923503 is an FDA 510(k) clearance for URIC ACID ENZYMATIC COLORIMERIC KIT, manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K923503

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.

KNK Device Classification - Class 1, General Controls

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 100
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K923503.
URIC ACID QVET
K943002 · Prisma Systems · Dec 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · Eastman Kodak Company · Apr 1994
IL TEST URIC ACID
K931350 · Instrumentation Laboratory CO · Oct 1993
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