Cleared Traditional

URIC ACID MODEL 3P39 (K102568) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

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 45
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
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
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · Eastman Kodak Company · Apr 1994
IL TEST URIC ACID
K931350 · Instrumentation Laboratory CO · Oct 1993
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503 · Randox Laboratories, Ltd. · Jul 1993