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 Jul 20, 2001
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
K012107
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
K010045
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
K011161
Syva Co., Dade Behring, Inc.
Toxicology · 29d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
K010651
Phamatech
Toxicology · 25d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
K002272
Branan Medical Corp.
Toxicology · 119d
Cleared Sep 28, 2000
MODIFICATION TO PROFILE -II
K002776
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared May 15, 2000
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
K000399
OraSure Technologies, Inc.
Toxicology · 98d
Cleared Apr 18, 2000
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
K000402
Drug Detection Devices, Ltd.
Toxicology · 71d
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