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
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
Cleared
Oct 15, 1987
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
Diagnostic Products Corp.
Toxicology
41d
Cleared
Nov 05, 1985
TDX PHENCYCLIDINE
Abbott Laboratories
Chemistry
21d
Cleared
Sep 27, 1984
EMIT 700 PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
21d
Cleared
Mar 22, 1984
EMIT ST SERUM PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
63d
Cleared
Mar 19, 1984
EMIT ST URINE PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
70d
Cleared
Mar 17, 1981
EMIT-ST SERUM PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
11d
Cleared
Feb 02, 1981
EMIT-ST PHENCYCLIDINE ASSAY
Syva Co.
Toxicology
20d
Cleared
Jun 15, 1979
PHENCYCLIDINE URINE ASSAY
Syva Co.
Toxicology
109d