Cleared Traditional

K102568 - URIC ACID MODEL 3P39

K102568 is an FDA 510(k) clearance for URIC ACID MODEL 3P39, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K102568 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
241d
Days
Class 1
Risk

K102568 is an FDA 510(k) clearance for the URIC ACID MODEL 3P39. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 6, 2011 after a review of 241 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K102568

510(k) Number K102568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date May 06, 2011
Days to Decision 241 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
153d slower than avg
Panel avg: 88d · This submission: 241d
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 K102568.
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862 · Olympus America, Inc. · Apr 2007
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 LIQUIDA
K023550 · Wiener Laboratories Saic · Dec 2002
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
K010421 · Wiener Laboratories Saic · Apr 2001