Cleared Traditional

K162200 - Randox RX Daytona Plus Magnesium (MG)

K162200 is an FDA 510(k) clearance for Randox RX Daytona Plus Magnesium (MG), manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K162200 · Randox Laboratories, Ltd. · Chemistry device
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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

FDA 510(k) Submission Details - K162200

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 88d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

JGJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JGJ Photometric Method, Magnesium

All 85
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K162200.
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