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 Phamatech.

88
Total
88
Cleared
97d
Avg days
1979
Since
88 devices
49–72 of 88
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 Dec 10, 1996
VERDICT PCP
K963692
Editek, Inc.
Toxicology · 85d
Cleared Oct 31, 1996
EZ-SCREEN PROFILE
K963233
Editek, Inc.
Toxicology · 73d
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 Dec 07, 1994
CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
K944605
Beckman-Diagnostic Systems Group
Toxicology · 79d
Cleared Sep 09, 1994
EZ-SCREEN:PCP
K943711
Editek, Inc.
Toxicology · 39d
Cleared Apr 12, 1994
USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
K935629
U.S. Drug Testing, Inc.
Toxicology · 140d
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 Dec 11, 1992
SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY
K924751
Solarcare Technologies Corp,Inc.
Toxicology · 79d
Cleared Nov 02, 1992
STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA
K924462
Solarcare Technologies Corp,Inc.
Toxicology · 61d
Cleared Jul 08, 1992
MICROLINE SCREEN FOR PHENCYCLIDINE
K921651
Drug Screening Systems, Inc.
Toxicology · 93d
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