Cleared Special

K040092 - AMEDITECH IMMU TEST DRUG SCREEN PANEL

K040092 is the FDA 510(k) clearance for AMEDITECH IMMU TEST DRUG SCREEN PANEL by Ameditech, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Special 510(k) pathway after a 52-day FDA review.

K040092 · Ameditech, Inc. · Toxicology device
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Mar 2004
Decision
52d
Days
Class 2
Risk

K040092 is an FDA 510(k) clearance for the AMEDITECH IMMU TEST DRUG SCREEN PANEL. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Ameditech, Inc. (San Diego, US). The FDA issued a Cleared decision on March 8, 2004 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ameditech, Inc. devices

Submission Details

510(k) Number K040092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2004
Decision Date March 08, 2004
Days to Decision 52 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K040092.
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685 · ACON Laboratories, Inc. · Aug 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd. · May 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · Dade Behring, Inc. · Apr 2004
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
K033094 · Lin-Zhi International, Inc. · Dec 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
K031759 · ACON Laboratories, Inc. · Aug 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · Dade Behring, Inc. · Jun 2003