Cleared Special

K991641 - AT HOME COCAINE & THC SCREENING TEST, MODEL 9170

K991641 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
20d
Days
-
Risk

K991641 is an FDA 510(k) clearance for the AT HOME COCAINE & THC SCREENING TEST, MODEL 9170. 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 June 1, 1999 after a review of 20 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.

FDA 510(k) Submission Details - K991641

510(k) Number K991641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1999
Decision Date June 01, 1999
Days to Decision 20 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
67d faster than avg
Panel avg: 87d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

MVO Device Classification - Class 0,

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 17
Devices cleared under the same product code (MVO) and FDA review panel - the closest regulatory comparables to K991641.
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
K992685 · Phamatech · Oct 1999
AT HOME DRUG TEST, MODEL 9175
K992217 · Phamatech · Jul 1999
AT HOME DRUG TEST, MODEL 9171
K991824 · Phamatech · Jun 1999
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150
K982621 · Phamatech · Oct 1998
K991641 · AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
Download PDF FDA Summary Phamatech