Cleared Traditional

K941195 - CEDIA DAU OPIATE ASSAY

K941195 is an FDA 510(k) clearance for CEDIA DAU OPIATE ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K941195 · Microgenics Corp. · Toxicology device
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Sep 1994
Decision
177d
Days
Class 2
Risk

K941195 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 September 7, 1994 after a review of 177 days - an extended review 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: 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 - K941195

510(k) Number K941195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date September 07, 1994
Days to Decision 177 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
90d slower than avg
Panel avg: 87d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K941195.
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · Princeton BioMeditech Corp. · Feb 1995
VISUALINE II MORPHINE/OPIATES/HEROIN
K943248 · Sun Biomedical Laboratories, Inc. · Jan 1995
CEDIA DAU OPIATE ASSAY
K945343 · Microgenics Corp. · Jan 1995
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp. · Jan 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · Syva Co. · Jan 1994
MICRO-PLATE OPIATES ASSAY
K924446 · Solarcare Technologies Corp,Inc. · Oct 1992