Cleared Traditional

RANDOX URIC ACID (K033278) - FDA 510(k) Clearance

Class I Chemistry device.

K033278 · Randox Laboratories, Ltd. · Chemistry device
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Feb 2004
Decision
140d
Days
Class 1
Risk

K033278 is an FDA 510(k) clearance for the RANDOX URIC ACID. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 27, 2004 after a review of 140 days - within the typical 510(k) review window.

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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K033278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2003
Decision Date February 27, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDO Acid, Uric, Uricase (u.v.)
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 - CDO Acid, Uric, Uricase (u.v.)

All 30
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K033278.
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