Cleared Special

K030447 - AT HOME DRUG CUP, MODEL 9150X

K030447 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
62d
Days
-
Risk

K030447 is an FDA 510(k) clearance for the AT HOME DRUG CUP, MODEL 9150X. 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 14, 2003 after a review of 62 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 - K030447

510(k) Number K030447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date April 14, 2003
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
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 K030447.
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
K040327 · Accu-Stat Diagnostics, Inc. · Apr 2004
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
K014192 · Princeton BioMeditech Corp. · May 2002
PEACE OF MIND HOME DRUG TEST
K013778 · Advantage Diagnostics Corp. · Feb 2002
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
K030447 · AT HOME DRUG CUP, MODEL 9150X
Download PDF FDA Summary Phamatech