Cleared Special

K053175 - AMEDITECH DRUGSMARTCUP

K053175 is the FDA 510(k) clearance for AMEDITECH DRUGSMARTCUP by Ameditech, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Special 510(k) pathway after a 24-day FDA review.

K053175 · Ameditech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
24d
Days
Class 2
Risk

K053175 is an FDA 510(k) clearance for the AMEDITECH DRUGSMARTCUP. 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 December 8, 2005 after a review of 24 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 K053175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date December 08, 2005
Days to Decision 24 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
63d faster than avg
Panel avg: 87d · This submission: 24d
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 K053175.
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
K063024 · Lin-Zhi International, Inc. · Oct 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc. · May 2006
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · Immunalysis Corporation · Oct 2005
EMIT II PLUS ECSTASY ASSAY
K043028 · Dade Behring, Inc. · Jan 2005
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822 · ACON Laboratories, Inc. · Sep 2004