Cleared Traditional

PEACE OF MIND HOME DRUG TEST (K013778) - FDA 510(k) Clearance

K013778 · Advantage Diagnostics Corp. · Toxicology device
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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.

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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 -