Cleared Traditional

AMEDITECH IMMUTEST DRUG SCREEN PCP (K012582) - FDA 510(k) Clearance

K012582 · Ameditech, Inc. · Toxicology device
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Nov 2001
Decision
112d
Days
-
Risk

K012582 is an FDA 510(k) clearance for the AMEDITECH IMMUTEST DRUG SCREEN PCP. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Ameditech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 30, 2001 after a review of 112 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 Ameditech, Inc. devices

Submission Details

510(k) Number K012582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date November 30, 2001
Days to Decision 112 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 87d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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PHENCYCLIDINE
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