Cleared Special

K010646 - AT HOME DRUG TEST

K010646 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
25d
Days
-
Risk

K010646 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9083 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 March 30, 2001 after a review of 25 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 devices

Submission Details

510(k) Number K010646 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.

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 11
Devices cleared under the same product code (MVO) and FDA review panel - the closest regulatory comparables to K010646.
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
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · Phamatech · Feb 2001
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
K992685 · Phamatech · Oct 1999
AT HOME DRUG TEST, MODEL 9175
K992217 · Phamatech · Jul 1999