Cleared Traditional

K860367 - MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)

K860367 is an FDA 510(k) clearance for MAGNESIUM (SUBSTRATE, manufactured by Alpkem Corp.. The device is a Class 2 Chemistry device with product code JGF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K860367 · Alpkem Corp. · Chemistry device
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Apr 1986
Decision
67d
Days
Class 2
Risk

K860367 is an FDA 510(k) clearance for the MAGNESIUM (SUBSTRATE, ENZYME, REAGENT). Classified as Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (product code JGF), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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 Alpkem Corp. devices

FDA 510(k) Submission Details - K860367

510(k) Number K860367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1986
Decision Date April 11, 1986
Days to Decision 67 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
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGF Device Classification - Class 2, Special Controls

Product Code JGF Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.