Cleared Special

K092737 - EASYRA MG REAGENT, MODEL 10220

K092737 is an FDA 510(k) clearance for EASYRA MG REAGENT, manufactured by Medica Corp.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Special 510(k) pathway after a 70-day FDA review.

K092737 · Medica Corp. · Chemistry device
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Nov 2009
Decision
70d
Days
Class 1
Risk

K092737 is an FDA 510(k) clearance for the EASYRA MG REAGENT, MODEL 10220. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 17, 2009 after a review of 70 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.

FDA 510(k) Submission Details - K092737

510(k) Number K092737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2009
Decision Date November 17, 2009
Days to Decision 70 days
Submission Type Special
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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 87
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K092737.
Atellica CH Magnesium (Mg)
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ACE MAGNESIUM REGENT
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MAGNESIUM ASSAY
K111915 · Sekisui Diagnostics P.E.I., Inc. · Dec 2011
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · Abaxis, Inc. · Oct 2009
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K063208 · Diagnostic Chemicals , Ltd. · Jan 2007
VITALAB MAGNESIUM REAGENT
K040508 · Clinical Data, Inc. · Mar 2004
K092737 · EASYRA MG REAGENT, MODEL 10220
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