# K111928: Psychemedics Phencyclidine Eia

- Pathway: 510(k) (Traditional)
- Applicant: Psychemedics Corp.
- Decided: May 1, 2012 after 300 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: 1 generation back to K011275 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011275: Psychemedics Ria Phencyclidine Assay, Psychemedics Corp. (2002) Summary page 1.

## Most influential descendants
- K212952: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (2022), 0 descendants of its own

## Indications for use
The Psychemnedics Microplate EIA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemnedics use only and is not intended for sale to anyone. The Psychemnedics EIA Phencyclidine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GQ/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

Source page: https://510kreport.com/device/K111928
Methodology: https://510kreport.com/methodology