Cleared Special

K010645 - AT HOME DRUG TEST, MODEL 9063 T

K010645 is an FDA 510(k) clearance for AT HOME DRUG TEST, manufactured by Phamatech. The device is a Class 2 Toxicology device with product code DKZ cleared through the Special 510(k) pathway after a 25-day FDA review.

K010645 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
25d
Days
Class 2
Risk

K010645 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9063 T. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 25 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 - K010645

510(k) Number K010645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date March 30, 2001
Days to Decision 25 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · This submission: 25d
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 K010645.
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · Sun Biomedical Laboratories, Inc. · May 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
K003809 · Rapid Diagnostics, Inc. · Apr 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · Medtox Diagnostics, Inc. · Apr 2001
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
K004034 · Branan Medical Corp. · Mar 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp. · Feb 2001
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
K002266 · Branan Medical Corporation · Nov 2000
K010645 · AT HOME DRUG TEST, MODEL 9063 T
Download PDF FDA Summary Phamatech