Cleared Traditional

K870370 - MAGNESIUM REAGENT - CALMAGITE METHOD

K870370 is the FDA 510(k) clearance for MAGNESIUM REAGENT - CALMAGITE METHOD by Trace Scientific , Ltd.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K870370 · Trace Scientific , Ltd. · Chemistry device
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Aug 1987
Decision
203d
Days
Class 1
Risk

K870370 is an FDA 510(k) clearance for the MAGNESIUM REAGENT - CALMAGITE METHOD. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on August 19, 1987 after a review of 203 days - an extended review 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: 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K870370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date August 19, 1987
Days to Decision 203 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
115d slower than avg
Panel avg: 88d · This submission: 203d
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 65
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K870370.
MAGNESIUM
K874847 · Tech-Co, Inc. · Dec 1987
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K872311 · Abbott Laboratories · Jul 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · Em Diagnostic Systems, Inc. · Mar 1987
MAGNESIOMETER
K863069 · J. D. Assoc. · Dec 1986