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..

88
Total
88
Cleared
97d
Avg days
1979
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Enzyme Immunoassay, Phencyclidine Devices (Product Code LCM)

88 devices
1–24 of 88
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

About Product Code LCM - Regulatory Context

510(k) Submission Activity

88 total 510(k) submissions under product code LCM since 1979, with 88 receiving FDA clearance (average review time: 97 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

LCM devices are reviewed by the Toxicology panel. Browse all Toxicology devices →