Cleared Traditional

K023550 - WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA

K023550 is an FDA 510(k) clearance for WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA, manufactured by Wiener Laboratories Saic. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K023550 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
48d
Days
Class 1
Risk

K023550 is an FDA 510(k) clearance for the WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on December 9, 2002 after a review of 48 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K023550

510(k) Number K023550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2002
Decision Date December 09, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 85
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K023550.
VITALAB URIC ACID REAGENT
K040467 · Clinical Data, Inc. · Mar 2004
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · Clinical Data, Inc. · Jul 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022096 · Bayer Diagnostics Corp. · Mar 2003
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
K010421 · Wiener Laboratories Saic · Apr 2001
WAKO L-TYPE UA F TEST
K993469 · Wako Chemicals USA, Inc. · Nov 1999
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919 · Beckman Instruments, Inc. · May 1997