Cleared Traditional

K010047 - INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST

K010047 · Alfa Scientific Designs, Inc. · Toxicology device
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May 2001
Decision
144d
Days
-
Risk

K010047 is an FDA 510(k) clearance for the INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K010047

510(k) Number K010047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2001
Decision Date May 29, 2001
Days to Decision 144 days
Submission Type Traditional
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
57d slower than avg
Panel avg: 87d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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