Cleared Special

K122302 - ACE MAGNESIUM REGENT (FDA 510(k) Clearance)

Class I Chemistry device.

K122302 · Alfa Wassermann Diagnostics Technologies, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
26d
Days
Class 1
Risk

K122302 is an FDA 510(k) clearance for the ACE MAGNESIUM REGENT. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Alfa Wassermann Diagnostics Technologies, LLC (West Caldwell, US). The FDA issued a Cleared decision on August 27, 2012 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alfa Wassermann Diagnostics Technologies, LLC devices

Submission Details

510(k) Number K122302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date August 27, 2012
Days to Decision 26 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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.