Cleared Traditional

K963654 - QUIKSTRIP ONESTEP MARIJUANA (THC) TEST

K963654 is an FDA 510(k) clearance for QUIKSTRIP ONESTEP MARIJUANA (THC) TEST, manufactured by Syntron Bioresearch, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K963654 · Syntron Bioresearch, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
169d
Days
Class 2
Risk

K963654 is an FDA 510(k) clearance for the QUIKSTRIP ONESTEP MARIJUANA (THC) TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Syntron Bioresearch, Inc. (Simi Valley, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 169 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 Syntron Bioresearch, Inc. devices

FDA 510(k) Submission Details - K963654

510(k) Number K963654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date February 28, 1997
Days to Decision 169 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
82d slower than avg
Panel avg: 87d · This submission: 169d
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 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K963654.
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841 · Bionike Laboratories, Inc. · Jun 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc. · Feb 1997
VERDICT THC
K963516 · Editek, Inc. · Oct 1996
VISUALINE COMBO V (COCAINE/THC) TEST
K963606 · Sun Biomedical Laboratories, Inc. · Oct 1996