Cleared Traditional

K841259 - DETERMINATION OF MAGNESIUM IN SERUM OR

K841259 is the FDA 510(k) clearance for DETERMINATION OF MAGNESIUM IN SERUM OR by Sigma Chemical Co.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K841259 · Sigma Chemical Co. · Chemistry device
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May 1984
Decision
42d
Days
Class 1
Risk

K841259 is an FDA 510(k) clearance for the DETERMINATION OF MAGNESIUM IN SERUM OR. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984 after a review of 42 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Chemical Co. devices

Submission Details

510(k) Number K841259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1984
Decision Date May 07, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

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.

Regulatory Peers - JGJ Photometric Method, Magnesium

All 64
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K841259.
MAGNESIUM
K853592 · Pointe Scientific, Inc., · Sep 1985
DATA-CHEM MAGNESIUM
K844278 · Data Medical Associates, Inc. · Jan 1985
MAGNESIUM ASSAY KIT
K843031 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
PARAMAX MAGNESIUM REAGENT
K840784 · American Dade · Apr 1984
MAGNESIUM B TEST
K834075 · Wako Chemicals USA, Inc. · Feb 1984
GIL CHEM MAGNESIUM REAGENT
K820976 · Gilford Diagnostics · Apr 1982