Cleared Traditional

K111928 - PSYCHEMEDICS PHENCYCLIDINE EIA

K111928 · Psychemedics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
300d
Days
-
Risk

K111928 is an FDA 510(k) clearance for the PSYCHEMEDICS PHENCYCLIDINE EIA. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Psychemedics Corp. devices

FDA 510(k) Submission Details - K111928

510(k) Number K111928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2011
Decision Date May 01, 2012
Days to Decision 300 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 88d · This submission: 300d
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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