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 Diagnostics Corp..
88
Total
88
Cleared
97d
Avg days
1979
Since
88 devices
Cleared
Feb 04, 1998
QUICKSCREEN ONE STEP PCP SCREENING TEST
Phamatech
Toxicology
58d
Cleared
Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
Boehringer Mannheim Corp.
Toxicology
42d
Cleared
Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
Roche Diagnostic Systems, Inc.
Toxicology
42d
Cleared
May 31, 1996
ACCUSIGN, BIOSIGN PCP
Princeton BioMeditech Corp.
Toxicology
59d
Cleared
Oct 26, 1995
AXSYM PHENCYCLIDINE II
Abbott Laboratories
Toxicology
91d
Cleared
Mar 20, 1995
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
62d
Cleared
Feb 22, 1995
EMIT IIC PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
484d
Cleared
Jan 17, 1995
CEDIA(R) DAU PCP ASSAY
Microgenics Corp.
Toxicology
36d
Cleared
Apr 05, 1994
CEDIA(R) DAU PCP ASSAY
Microgenics Corp.
Toxicology
133d
Cleared
Dec 29, 1993
PHENCYCLIDINE EIA ASSAY
Diagnostic Reagents, Inc.
Toxicology
76d
Cleared
Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
Roche Diagnostic Systems, Inc.
Toxicology
19d
Cleared
Mar 18, 1992
PHENCYCLIDINE EIA ASSAY, MODIFICATION
Diagnostic Reagents, Inc.
Toxicology
49d
Cleared
Jan 27, 1992
EMIT D.A.U. PHENCYCLIDINE ASSAY
Syva Co.
Chemistry
38d
Cleared
Dec 09, 1991
PHENCYCLIDINE EIA ASSAY
Diagnostic Reagents, Inc.
Toxicology
24d
Cleared
Nov 07, 1991
IL TEST(TM) PHENCYCLIDINE
Instrumentation Laboratory CO
Toxicology
79d
Cleared
Jun 18, 1991
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
Immunotech Corp.
Toxicology
95d
Cleared
Jun 03, 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
47d
Cleared
Nov 28, 1990
EMIT (R) II PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
37d
Cleared
Aug 17, 1990
MILENIA(TM) PCP
Diagnostic Products Corp.
Toxicology
43d
Cleared
Apr 26, 1990
HYCOR ACCUPINCH PHENCYCLIDINE TEST
Hycor Biomedical, Inc.
Toxicology
58d
Cleared
Apr 25, 1990
TDX PHENCYCLIDINE II ASSAY
Abbott Laboratories
Toxicology
56d
Cleared
Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
Roche Diagnostic Systems, Inc.
Toxicology
112d
Cleared
Aug 25, 1989
ADX TM PHENCYCLIDINE
Abbott Laboratories
Toxicology
192d
Cleared
Nov 13, 1987
REVISED LABELING FOR PCP TEST KIT
Roche Diagnostic Systems, Inc.
Toxicology
24d