Cleared Traditional

K943710 - VERDICT COCAINE

K943710 is an FDA 510(k) clearance for VERDICT COCAINE, manufactured by Editek, Inc.. The device is a Class 2 Chemistry device with product code DIO cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K943710 · Editek, Inc. · Chemistry device
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Nov 1994
Decision
108d
Days
Class 2
Risk

K943710 is an FDA 510(k) clearance for the VERDICT COCAINE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), 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 Chemistry FDA review panel, regulated under 21 CFR 862.3250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Editek, Inc. devices

FDA 510(k) Submission Details - K943710

510(k) Number K943710 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 Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 110
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K943710.
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