Cleared Traditional

K901544 - WAKO(TM) AUTOKIT URIC ACID

K901544 is the FDA 510(k) clearance for WAKO(TM) AUTOKIT URIC ACID by Wako Chemicals USA, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K901544 · Wako Chemicals USA, Inc. · Chemistry device
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May 1990
Decision
41d
Days
Class 1
Risk

K901544 is an FDA 510(k) clearance for the WAKO(TM) AUTOKIT URIC ACID. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on May 14, 1990 after a review of 41 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K901544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date May 14, 1990
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 K901544.
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
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · Technicon Instruments Corp. · Apr 1990
COULTER URIC ACID REAGENT
K897161 · Coulter Electronics, Inc. · Mar 1990
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954 · Abbott Laboratories · Feb 1990