LCM

FDA Product Code LCM: Enzyme Immunoassay, Phencyclidine

FDA product code LCM covers enzyme immunoassay systems for the detection of phencyclidine (PCP) in biological specimens.

These tests use antibody-based technology to screen for PCP — a dissociative hallucinogen — in urine. PCP testing is included in standard emergency toxicology panels and workplace drug screening programs due to the drug's potential for severe psychiatric and behavioral effects.

LCM devices are reviewed by the FDA Toxicology panel.

Leading manufacturers include Immunalysis Corporation and Siemens Healthcare Diagnostics, Inc..

4
Total
4
Cleared
146d
Avg days
2015
Since

List of Enzyme Immunoassay, Phencyclidine devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Apr 20, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489
Immunalysis Corporation
Toxicology · 144d
Cleared Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135
Immunalysis Corporation
Toxicology · 269d
Cleared Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
K163220
Siemens Healthcare Diagnostics, Inc.
Toxicology · 141d
Cleared Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176
Immunalysis Corporation
Toxicology · 31d

How to use this database

This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Phencyclidine devices (product code LCM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →