Cleared Traditional

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST (K963654) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963654 · Syntron Bioresearch, Inc. · Toxicology device
Download Printable Device Report (PDF)
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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

Submission Details

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
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.

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 149
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