Cleared Traditional

K024014 - RANDOX RX DAYTONA

K024014 is an FDA 510(k) clearance for RANDOX RX DAYTONA, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K024014 · Randox Laboratories, Ltd. · Chemistry device
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Dec 2003
Decision
365d
Days
Class 2
Risk

K024014 is an FDA 510(k) clearance for the RANDOX RX DAYTONA. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on December 4, 2003 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K024014

510(k) Number K024014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date December 04, 2003
Days to Decision 365 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 88d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 300
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