Cleared Traditional

K040467 - VITALAB URIC ACID REAGENT

K040467 is the FDA 510(k) clearance for VITALAB URIC ACID REAGENT by Clinical Data, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K040467 · Clinical Data, Inc. · Chemistry device
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Mar 2004
Decision
13d
Days
Class 1
Risk

K040467 is an FDA 510(k) clearance for the VITALAB URIC ACID REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 8, 2004 after a review of 13 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K040467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2004
Decision Date March 08, 2004
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 58
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K040467.
URIC ACID MODEL 3P39
K102568 · Abbott Laboratories · May 2011
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
URIC ACID (LIQUID) REAGENT SET
K970560 · Pointe Scientific, Inc., · Mar 1997
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586 · Diagnostic Chemicals , Ltd. · Jul 1996