Cleared Traditional

K940649 - CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT

K940649 is an FDA 510(k) clearance for CEDIA DAU MULTI-LEVEL THC ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K940649 · Microgenics Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
91d
Days
Class 2
Risk

K940649 is an FDA 510(k) clearance for the CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REA.... 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 May 17, 1994 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corp. devices

FDA 510(k) Submission Details - K940649

510(k) Number K940649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1994
Decision Date May 17, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 126
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K940649.
CANNABINOID EIA ASSAY
K943998 · Diagnostic Reagents, Inc. · Nov 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562 · Microgenics Corp. · Nov 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · Microgenics Corp. · Aug 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · Microgenics Corp. · Jan 1994
EMIT(R) THC 50/100 NG ASSAY
K932716 · Syva Co. · Oct 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
K931598 · Biosite Incorporated · May 1993