# K212952: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

- Pathway: 510(k) (Traditional)
- Applicant: Psychemedics Corporation
- Decided: Apr 18, 2022 after 214 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011275 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111928: Psychemedics Phencyclidine Eia, Psychemedics Corp. (2012) Summary page 4.

## Indications for use
The Psychemedics homogeneous enzyme immunoassay (HEIA) for phencyclidine in hair is an enzyme immunoassay system for the preliminary qualitative detection of phencyclidine in human head and body hair using a phencyclidine calibrator at 3 ng phencyclidine/10 mg hair for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics phencyclidine homogeneous enzyme immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS), is the preferred confirmatory method.

Source page: https://510kreport.com/device/K212952
Methodology: https://510kreport.com/methodology