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 Syva Co., Abbott Laboratories and Roche Diagnostics Corp..

88
Total
88
Cleared
97d
Avg days
1979
Since
88 devices
25–48 of 88
Cleared Feb 04, 1998
QUICKSCREEN ONE STEP PCP SCREENING TEST
K974582
Phamatech
Toxicology · 58d
Cleared Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
K972963
Boehringer Mannheim Corp.
Toxicology · 42d
Cleared Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
K964355
Roche Diagnostic Systems, Inc.
Toxicology · 42d
Cleared May 31, 1996
ACCUSIGN, BIOSIGN PCP
K961266
Princeton BioMeditech Corp.
Toxicology · 59d
Cleared Oct 26, 1995
AXSYM PHENCYCLIDINE II
K953534
Abbott Laboratories
Toxicology · 91d
Cleared Mar 20, 1995
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950183
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 62d
Cleared Feb 22, 1995
EMIT IIC PHENCYCLIDINE ASSAY
K935191
Syva Co.
Toxicology · 484d
Cleared Jan 17, 1995
CEDIA(R) DAU PCP ASSAY
K946059
Microgenics Corp.
Toxicology · 36d
Cleared Apr 05, 1994
CEDIA(R) DAU PCP ASSAY
K935650
Microgenics Corp.
Toxicology · 133d
Cleared Dec 29, 1993
PHENCYCLIDINE EIA ASSAY
K935320
Diagnostic Reagents, Inc.
Toxicology · 76d
Cleared Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
K920935
Roche Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Mar 18, 1992
PHENCYCLIDINE EIA ASSAY, MODIFICATION
K920957
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Jan 27, 1992
EMIT D.A.U. PHENCYCLIDINE ASSAY
K915728
Syva Co.
Chemistry · 38d
Cleared Dec 09, 1991
PHENCYCLIDINE EIA ASSAY
K915179
Diagnostic Reagents, Inc.
Toxicology · 24d
Cleared Nov 07, 1991
IL TEST(TM) PHENCYCLIDINE
K913743
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Jun 18, 1991
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K911153
Immunotech Corp.
Toxicology · 95d
Cleared Jun 03, 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Nov 28, 1990
EMIT (R) II PHENCYCLIDINE ASSAY
K904765
Syva Co.
Toxicology · 37d
Cleared Aug 17, 1990
MILENIA(TM) PCP
K902960
Diagnostic Products Corp.
Toxicology · 43d
Cleared Apr 26, 1990
HYCOR ACCUPINCH PHENCYCLIDINE TEST
K900921
Hycor Biomedical, Inc.
Toxicology · 58d
Cleared Apr 25, 1990
TDX PHENCYCLIDINE II ASSAY
K900940
Abbott Laboratories
Toxicology · 56d
Cleared Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Aug 25, 1989
ADX TM PHENCYCLIDINE
K890688
Abbott Laboratories
Toxicology · 192d
Cleared Nov 13, 1987
REVISED LABELING FOR PCP TEST KIT
K874267
Roche Diagnostic Systems, Inc.
Toxicology · 24d