Cleared Traditional

K943712 - VERDICT OPIATES

K943712 is an FDA 510(k) clearance for VERDICT OPIATES, manufactured by Editek, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K943712 · Editek, Inc. · Toxicology device
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Nov 1994
Decision
108d
Days
Class 2
Risk

K943712 is an FDA 510(k) clearance for the VERDICT OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Editek, Inc. (Burlington, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 108 days - within the typical 510(k) review window.

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 Editek, Inc. devices

FDA 510(k) Submission Details - K943712

510(k) Number K943712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date November 17, 1994
Days to Decision 108 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 87d · This submission: 108d
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 178
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K943712.
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 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