Cleared Traditional

K901001 - URIC ACID TEST KIT

K901001 is an FDA 510(k) clearance for URIC ACID TEST KIT, manufactured by Elite Technology, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K901001 · Elite Technology, Inc. · Chemistry device
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May 1990
Decision
82d
Days
Class 1
Risk

K901001 is an FDA 510(k) clearance for the URIC ACID TEST KIT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on May 23, 1990 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elite Technology, Inc. devices

FDA 510(k) Submission Details - K901001

510(k) Number K901001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date May 23, 1990
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 K901001.
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
WAKO(TM) AUTOKIT URIC ACID
K901544 · Wako Chemicals USA, Inc. · May 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · Technicon Instruments Corp. · Apr 1990
COULTER URIC ACID REAGENT
K897161 · Coulter Electronics, Inc. · Mar 1990