Cleared Special

K992685 - QUICKSCREEN WORKPLACE DRUG SCREENING TEST

K992685 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
57d
Days
-
Risk

K992685 is an FDA 510(k) clearance for the QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C. 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 6, 1999 after a review of 57 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.

View all Phamatech devices

Submission Details

510(k) Number K992685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date October 06, 1999
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 11
Devices cleared under the same product code (MVO) and FDA review panel - the closest regulatory comparables to K992685.
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · Phamatech · Apr 2001
AT HOME DRUG TEST, MODEL 9083 T
K010646 · Phamatech · Mar 2001
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · Phamatech · Feb 2001
AT HOME DRUG TEST, MODEL 9175
K992217 · Phamatech · Jul 1999
AT HOME DRUG TEST, MODEL 9171
K991824 · Phamatech · Jun 1999
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
K991641 · Phamatech · Jun 1999