Cleared Traditional

K013778 - PEACE OF MIND HOME DRUG TEST

K013778 · Advantage Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
86d
Days
-
Risk

K013778 is an FDA 510(k) clearance for the PEACE OF MIND HOME DRUG TEST. Classified as Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (product code MVO).

Submitted by Advantage Diagnostics Corp. (Redwood City, US). The FDA issued a Cleared decision on February 7, 2002 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advantage Diagnostics Corp. devices

Submission Details

510(k) Number K013778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date February 07, 2002
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 87d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

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 K013778.
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