Cleared Traditional

AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (K023109) - FDA 510(k) Clearance

K023109 · Amedica Biotech, Inc. · Toxicology device
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Dec 2002
Decision
89d
Days
-
Risk

K023109 is an FDA 510(k) clearance for the AMEDICA DRUG SCREEN PHENCYCLIDINE TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Amedica Biotech, Inc. (Hayward, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amedica Biotech, Inc. devices

Submission Details

510(k) Number K023109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date December 16, 2002
Days to Decision 89 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 87d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 87
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PHENCYCLIDINE
K013096 · Abbott Laboratories · Mar 2002