Cleared Traditional

K012326 - WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001

K012326 is an FDA 510(k) clearance for WIENER LAB.MG-COLOR AA, manufactured by Wiener Laboratories Saic. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K012326 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
108d
Days
Class 1
Risk

K012326 is an FDA 510(k) clearance for the WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on November 8, 2001 after a review of 108 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K012326

510(k) Number K012326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date November 08, 2001
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
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 K012326.
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
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · Abaxis, Inc. · Jan 2004
JAS MAGNESIUM REAGENT
K003835 · Jas Diagnostics, Inc. · Mar 2001
MAGNESIUM PRODUCT NO'S, 112-01, 112-02
K991761 · A.P. Total Care, Inc. · Sep 1999
CARESIDE MG
K991717 · Careside, Inc. · Aug 1999