Cleared Special

K010653 - AT HOME DRUG TEST, MODEL 9068 T

K010653 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
31d
Days
-
Risk

K010653 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9068 T. Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 5, 2001 after a review of 31 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.

FDA 510(k) Submission Details - K010653

510(k) Number K010653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date April 05, 2001
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

MVO Device Classification - Class 0,

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 17
Devices cleared under the same product code (MVO) and FDA review panel - the closest regulatory comparables to K010653.
AT HOME DRUG TEST, MODEL 9074
K013409 · Phamatech, Inc. · Dec 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · Phamatech, Inc. · Dec 2001
AT HOME DRUG TEST, MODEL 9069
K013412 · Phamatech, Inc. · Dec 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
K010653 · AT HOME DRUG TEST, MODEL 9068 T
Download PDF FDA Summary Phamatech