Cleared Traditional

K140546 - HEALGEN THC ONE STEP MARIJUANA TEST

K140546 is the FDA 510(k) clearance for HEALGEN THC ONE STEP MARIJUANA TEST by Healgen Scientific, LLC. It is a Class 2 Chemistry device (product code LDJ) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K140546 · Healgen Scientific, LLC · Chemistry device
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Jun 2014
Decision
94d
Days
Class 2
Risk

K140546 is an FDA 510(k) clearance for the HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Healgen Scientific, LLC (Gaithersburg, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - 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 Healgen Scientific, LLC devices

Submission Details

510(k) Number K140546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date June 06, 2014
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 86
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