Cleared Traditional

K945343 - CEDIA DAU OPIATE ASSAY

K945343 is the FDA 510(k) clearance for CEDIA DAU OPIATE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K945343 · Microgenics Corp. · Toxicology device
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Jan 1995
Decision
77d
Days
Class 2
Risk

K945343 is an FDA 510(k) clearance for the CEDIA DAU OPIATE ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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: 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 K945343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date January 17, 1995
Days to Decision 77 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
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K945343.
AXSYM OPIATES
K951287 · Abbott Laboratories · May 1995
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · Princeton BioMeditech Corp. · Feb 1995
CEDIA DAU OPIATE ASSAY
K941195 · Microgenics Corp. · Sep 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp. · Jan 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · Syva Co. · Jan 1994