Cleared Traditional

QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 (K982621) - FDA 510(k) Clearance

K982621 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
80d
Days
-
Risk

K982621 is an FDA 510(k) clearance for the QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150. 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 October 16, 1998 after a review of 80 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 Phamatech devices

Submission Details

510(k) Number K982621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1998
Decision Date October 16, 1998
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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