Cleared Traditional

K011813 - AMEDITECH IMMUTEST DRUG SCREEN THC

K011813 is an FDA 510(k) clearance for AMEDITECH IMMUTEST DRUG SCREEN THC, manufactured by Ameditech, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K011813 · Ameditech, Inc. · Toxicology device
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Oct 2001
Decision
133d
Days
Class 2
Risk

K011813 is an FDA 510(k) clearance for the AMEDITECH IMMUTEST DRUG SCREEN THC. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Ameditech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 22, 2001 after a review of 133 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.

FDA 510(k) Submission Details - K011813

510(k) Number K011813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2001
Decision Date October 22, 2001
Days to Decision 133 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 87d · This submission: 133d
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 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K011813.
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · Princeton BioMeditech Corp. · May 2002
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
NO STEP ON SITE DEUG TEST CUP
K012390 · Drug Free Enterprises · Dec 2001
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
K012541 · Branan Medical Corp. · Sep 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · Advantage Diagnostics Corp. · Jun 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · Syva Co., Dade Behring, Inc. · May 2001
K011813 · AMEDITECH IMMUTEST DRUG SCREEN THC
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