Cleared Special

K010651 - AT HOME DRUG TEST, MODEL 9133 T

K010651 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Mar 2001
Decision
25d
Days
-
Risk

K010651 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9133 T. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 25 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.

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FDA 510(k) Submission Details - K010651

510(k) Number K010651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date March 30, 2001
Days to Decision 25 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
62d faster than avg
Panel avg: 87d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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