Cleared Traditional

MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 (K003858) - FDA 510(k) Clearance

K003858 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 2001
Decision
61d
Days
-
Risk

K003858 is an FDA 510(k) clearance for the MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175. 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 February 12, 2001 after a review of 61 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 K003858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2000
Decision Date February 12, 2001
Days to Decision 61 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
26d faster than avg
Panel avg: 87d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class -