Cleared Traditional

K111915 - MAGNESIUM ASSAY

K111915 is an FDA 510(k) clearance for MAGNESIUM ASSAY, manufactured by Sekisui Diagnostics P.E.I., Inc.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K111915 · Sekisui Diagnostics P.E.I., Inc. · Chemistry device
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Dec 2011
Decision
149d
Days
Class 1
Risk

K111915 is an FDA 510(k) clearance for the MAGNESIUM ASSAY. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Sekisui Diagnostics P.E.I., Inc. (Prince Edward Island, CA). The FDA issued a Cleared decision on December 2, 2011 after a review of 149 days - within the typical 510(k) review window.

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 Sekisui Diagnostics P.E.I., Inc. devices

FDA 510(k) Submission Details - K111915

510(k) Number K111915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2011
Decision Date December 02, 2011
Days to Decision 149 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
61d slower than avg
Panel avg: 88d · This submission: 149d
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 72
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K111915.
Magnesium
K173294 · Abbott Laboratories · May 2018
Randox RX Daytona Plus Magnesium (MG)
K162200 · Randox Laboratories, Ltd. · Apr 2017
Atellica CH Magnesium (Mg)
K162399 · Siemens Healthcare Diagnostics, Inc. · Jan 2017
EASYRA MG REAGENT, MODEL 10220
K092737 · Medica Corp. · Nov 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