Cleared Traditional

K012390 - NO STEP ON SITE DEUG TEST CUP

K012390 is an FDA 510(k) clearance for NO STEP ON SITE DEUG TEST CUP, manufactured by Drug Free Enterprises. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K012390 · Drug Free Enterprises · Toxicology device
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Dec 2001
Decision
144d
Days
Class 2
Risk

K012390 is an FDA 510(k) clearance for the NO STEP ON SITE DEUG TEST CUP. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Drug Free Enterprises (West Los Angeles, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 144 days - within the typical 510(k) review window.

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 Drug Free Enterprises devices

FDA 510(k) Submission Details - K012390

510(k) Number K012390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2001
Decision Date December 18, 2001
Days to Decision 144 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 87d · This submission: 144d
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 127
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K012390.
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066 · Princeton BioMeditech Corp. · Jun 2002
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · Princeton BioMeditech Corp. · May 2002
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · Syva Co., Dade Behring, Inc. · May 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
PROFILE II ER
K010138 · Medtox Diagnostics, Inc. · Feb 2001