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 Diagnostic Systems, Inc..

88
Total
88
Cleared
97d
Avg days
1979
Since
88 devices
25–48 of 88
Cleared May 15, 2000
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
K000399
OraSure Technologies, Inc.
Toxicology · 98d
Cleared Apr 06, 2000
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K000462
Dade Behring, Inc.
Toxicology · 55d
Cleared Jan 27, 2000
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
K993983
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
K994017
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
K994020
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
K994030
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9133
K994236
Phamatech
Toxicology · 14d
Cleared Dec 07, 1999
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
K993945
Bionike Laboratories, Inc.
Toxicology · 18d
Cleared Aug 25, 1999
REDI-TEST PCP
K991698
Redwood Biotech, Inc.
Toxicology · 99d
Cleared Aug 05, 1999
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
K991505
Microdiagnostics, Inc.
Toxicology · 98d
Cleared Mar 01, 1999
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
K983790
Sun Biomedical Laboratories, Inc.
Toxicology · 125d
Cleared Dec 22, 1998
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
K981363
Tcpi, Inc.
Toxicology · 251d
Cleared Nov 04, 1998
AUTO-LYTE PCP EIA, MODEL #1254U
K982801
OraSure Technologies, Inc.
Toxicology · 86d
Cleared May 26, 1998
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
K981292
Syntron Bioresearch, Inc.
Toxicology · 47d
Cleared May 07, 1998
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
K981019
Syntron Bioresearch, Inc.
Toxicology · 50d
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 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