Cleared Traditional

K040467 - VITALAB URIC ACID REAGENT

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

K040467 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K040467

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNK Acid, Uric, Uricase (colorimetric)

All 100
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
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
JAS URIC ACID LIQUID REAGENT
K012038 · Jas Diagnostics, Inc. · Aug 2001