Cleared Traditional

K963516 - VERDICT THC

K963516 is an FDA 510(k) clearance for VERDICT THC, manufactured by Editek, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K963516 · Editek, Inc. · Toxicology device
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Oct 1996
Decision
57d
Days
Class 2
Risk

K963516 is an FDA 510(k) clearance for the VERDICT THC. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Editek, Inc. (Burlington, US). The FDA issued a Cleared decision on October 30, 1996 after a review of 57 days - a notably fast clearance cycle.

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: 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 Editek, Inc. devices

FDA 510(k) Submission Details - K963516

510(k) Number K963516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date October 30, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
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 119
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K963516.
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · Syntron Bioresearch, Inc. · Feb 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc. · Feb 1997
VISUALINE COMBO V (COCAINE/THC) TEST
K963606 · Sun Biomedical Laboratories, Inc. · Oct 1996
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
K951853 · Tcpi, Inc. · Aug 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · Beckman Instruments, Inc. · Apr 1996