Cleared Traditional

K162200 - Randox RX Daytona Plus Magnesium (MG) (FDA 510(k) Clearance)

Class I Chemistry device.

K162200 · Randox Laboratories, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
266d
Days
Class 1
Risk

K162200 is an FDA 510(k) clearance for the Randox RX Daytona Plus Magnesium (MG). Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on April 28, 2017 after a review of 266 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - 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 K162200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date April 28, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 88d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGJ Photometric Method, Magnesium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1495
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.