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 Syva Co., Abbott Laboratories and Roche Diagnostic Systems, 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
Cleared
Apr 18, 2022
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
Psychemedics Corporation
Toxicology
214d
Cleared
Apr 20, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay
Immunalysis Corporation
Toxicology
144d
Cleared
Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
Immunalysis Corporation
Toxicology
269d
Cleared
Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
Siemens Healthcare Diagnostics, Inc.
Toxicology
141d
Cleared
Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Immunalysis Corporation
Toxicology
31d
Cleared
Aug 25, 2014
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry
28d
Cleared
Jun 25, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
Omega Laboratories, Inc.
Toxicology
61d
Cleared
Apr 25, 2013
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
Biophor Diagnostics, Inc.
Toxicology
233d
Cleared
May 01, 2012
PSYCHEMEDICS PHENCYCLIDINE EIA
Psychemedics Corp.
Chemistry
300d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
Microgenics Corp.
Chemistry
290d
Cleared
Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
Roche Diagnostics
Chemistry
397d
Cleared
Nov 22, 2006
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V
Ortho-Clinical Diagnostics, Inc.
Chemistry
121d
Cleared
Jul 28, 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
Quest Diagnostics, Inc.
Toxicology
300d
Cleared
Jan 27, 2005
RANDOX PHENCYCLIDINE ASSAY
Randox Laboratories, Ltd.
Chemistry
80d
Cleared
Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
Roche Diagnostics Corp.
Toxicology
41d
Cleared
Sep 10, 2004
QUICKSCREEN, MODELS 9177X AND 9178X
Phamatech
Chemistry
88d
Cleared
May 10, 2002
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
Lin-Zhi International, Inc.
Toxicology
106d
Cleared
Mar 13, 2002
PHENCYCLIDINE
Abbott Laboratories
Toxicology
177d
Cleared
Aug 09, 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
ACON Laboratories, Inc.
Toxicology
65d
Cleared
May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
Alfa Scientific Designs, Inc.
Toxicology
144d
Cleared
May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
Alfa Scientific Designs, Inc.
Toxicology
144d
Cleared
May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
Syva Co., Dade Behring, Inc.
Toxicology
29d
Cleared
Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
Phamatech
Toxicology
25d
Cleared
Sep 28, 2000
MODIFICATION TO PROFILE -II
Medtox Diagnostics, Inc.
Toxicology
22d
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.