Cleared Traditional

K963207 - QUICKPAC II ONE STEP MARIJUANA (THC) TEST

K963207 is the FDA 510(k) clearance for QUICKPAC II ONE STEP MARIJUANA (THC) TEST by Drial Consultants, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K963207 · Drial Consultants, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
189d
Days
Class 2
Risk

K963207 is an FDA 510(k) clearance for the QUICKPAC II ONE STEP MARIJUANA (THC) TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Drial Consultants, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 189 days - an extended review 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: 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 Drial Consultants, Inc. devices

Submission Details

510(k) Number K963207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date February 20, 1997
Days to Decision 189 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 87d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K963207.
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 1997
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · Beckman Instruments, Inc. · Apr 1996
FRONTLINE CANNABIS
K954497 · Boehringer Mannheim Corp. · Mar 1996
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995