Cleared Traditional

K912028 - URIC ACID (URICASE) REAGENT, UNIVERSAL

K912028 is an FDA 510(k) clearance for URIC ACID (URICASE) REAGENT, manufactured by Enzyme Technology, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K912028 · Enzyme Technology, Inc. · Chemistry device
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Dec 1991
Decision
224d
Days
Class 1
Risk

K912028 is an FDA 510(k) clearance for the URIC ACID (URICASE) REAGENT, UNIVERSAL. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Enzyme Technology, Inc. (Shelton, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 224 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 Enzyme Technology, Inc. devices

FDA 510(k) Submission Details - K912028

510(k) Number K912028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1991
Decision Date December 18, 1991
Days to Decision 224 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
136d slower than avg
Panel avg: 88d · This submission: 224d
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 101
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K912028.
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS URIC ACID REAGENT
K922756 · Olympus Corp. · Jul 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc. · Jul 1992
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · Em Diagnostic Systems, Inc. · Sep 1991
SYNERMED URIC ACID REAGENT KIT
K903727 · Synermed, Inc. · Sep 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · Roche Diagnostic Systems, Inc. · Jun 1990