Cleared Special

K013409 - AT HOME DRUG TEST

K013409 · Phamatech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
52d
Days
-
Risk

K013409 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9074. Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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 Phamatech, Inc. devices

Submission Details

510(k) Number K013409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 06, 2001
Days to Decision 52 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
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 MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class -

Regulatory Peers - MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

All 12
Devices cleared under the same product code (MVO) and FDA review panel - the closest regulatory comparables to K013409.
AT HOME DRUG CUP, MODEL 9150X
K030447 · Phamatech · Apr 2003
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
K014192 · Princeton BioMeditech Corp. · May 2002
AT HOME DRUG TEST, MODEL 9068 T
K010653 · Phamatech · Apr 2001
AT HOME DRUG TEST, MODEL 9078 T
K010654 · Phamatech · Apr 2001
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · Phamatech · Apr 2001
AT HOME DRUG TEST, MODEL 9083 T
K010646 · Phamatech · Mar 2001