Cleared Traditional

K011814 - AMEDITECH IMMUTEST DRUG SCREEN COC

K011814 is the FDA 510(k) clearance for AMEDITECH IMMUTEST DRUG SCREEN COC by Ameditech, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K011814 · Ameditech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
133d
Days
Class 2
Risk

K011814 is an FDA 510(k) clearance for the AMEDITECH IMMUTEST DRUG SCREEN COC. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), 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 862.3250 - 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 Ameditech, Inc. devices

Submission Details

510(k) Number K011814 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
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.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K011814.
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
K020763 · Lin-Zhi International, Inc. · May 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · Dade Behring, Inc. · Mar 2002
COCAINE
K013004 · Abbott Laboratories · Mar 2002
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · ACON Laboratories, Inc. · Jul 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · Teco Diagnostics · Jun 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · Phamatech · Apr 2001