Cleared Traditional

K944562 - MULTI LEVEL THC ASSAY

K944562 is the FDA 510(k) clearance for MULTI LEVEL THC ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code LDJ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K944562 · Microgenics Corp. · Chemistry device
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Nov 1994
Decision
64d
Days
Class 2
Risk

K944562 is an FDA 510(k) clearance for the MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - 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 Microgenics Corp. devices

Submission Details

510(k) Number K944562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date November 02, 1994
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K944562.
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
K944086 · Beckman Instruments, Inc. · Dec 1994
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
K944088 · Beckman Instruments, Inc. · Nov 1994
CANNABINOID EIA ASSAY
K943998 · Diagnostic Reagents, Inc. · Nov 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · Microgenics Corp. · Aug 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
K940649 · Microgenics Corp. · May 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · Microgenics Corp. · Jan 1994