Cleared Traditional

K031044 - ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (FDA 510(k) Clearance)

Class I Toxicology device.

K031044 · Clinical Data, Inc. · Toxicology device
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Jul 2003
Decision
105d
Days
Class 1
Risk

K031044 is an FDA 510(k) clearance for the ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR. 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 July 15, 2003 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1775 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Data, Inc. devices

Submission Details

510(k) Number K031044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2003
Decision Date July 15, 2003
Days to Decision 105 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 87d · This submission: 105d
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.