Cleared Special

K040092 - AMEDITECH IMMU TEST DRUG SCREEN PANEL

K040092 is an FDA 510(k) clearance for AMEDITECH IMMU TEST DRUG SCREEN PANEL, manufactured by Ameditech, Inc.. The device is a Class 2 Toxicology device with 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.

FDA 510(k) Submission Details - K040092

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

DKZ Device Classification - Class 2, Special Controls

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 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K040092.
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd. · May 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · Dade Behring, Inc. · Apr 2004
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22
K040203 · Branan Medical Corp. · Mar 2004
ONTRAK TESTCUP II AND ONSITE CUPKIT
K033902 · Varian, Inc. · Jan 2004
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
K033659 · Varian, Inc. · Jan 2004
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
K033094 · Lin-Zhi International, Inc. · Dec 2003
K040092 · AMEDITECH IMMU TEST DRUG SCREEN PANEL
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