K212952 - Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (FDA 510(k) Clearance)

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.

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