Cleared Traditional

K011275 - PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY

K011275 · Psychemedics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
291d
Days
-
Risk

K011275 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 291 days - an extended review 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: 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 Psychemedics Corp. devices

FDA 510(k) Submission Details - K011275

510(k) Number K011275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2001
Decision Date February 11, 2002
Days to Decision 291 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
204d slower than avg
Panel avg: 87d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

LCL Device Classification - Class 0,

Product Code LCL Radioimmunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCL Radioimmunoassay, Phencyclidine

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