Cleared Traditional

K212952 - Psychemedics Homogeneous Enzyme Immunoa...

K212952 · Psychemedics Corporation · Toxicology device
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Apr 2022
Decision
214d
Days
-
Risk

K212952 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on April 18, 2022 after a review of 214 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 Corporation devices

FDA 510(k) Submission Details - K212952

510(k) Number K212952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2021
Decision Date April 18, 2022
Days to Decision 214 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
127d slower than avg
Panel avg: 87d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 62
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