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
73–88 of 88
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
Cleared Oct 15, 1987
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
K873756
Diagnostic Products Corp.
Toxicology · 41d
Cleared Nov 05, 1985
TDX PHENCYCLIDINE
K854167
Abbott Laboratories
Chemistry · 21d
Cleared Sep 18, 1985
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
K853548
American Dade
Chemistry · 23d
Cleared Sep 27, 1984
EMIT 700 PHENCYCLIDINE ASSAY
K843509
Syva Co.
Toxicology · 21d
Cleared Mar 22, 1984
EMIT ST SERUM PHENCYCLIDINE ASSAY
K840199
Syva Co.
Toxicology · 63d
Cleared Mar 19, 1984
EMIT ST URINE PHENCYCLIDINE ASSAY
K840061
Syva Co.
Toxicology · 70d
Cleared Mar 17, 1981
EMIT-ST SERUM PHENCYCLIDINE ASSAY
K810601
Syva Co.
Toxicology · 11d
Cleared Feb 02, 1981
EMIT-ST PHENCYCLIDINE ASSAY
K810093
Syva Co.
Toxicology · 20d
Cleared Jun 15, 1979
PHENCYCLIDINE URINE ASSAY
K790401
Syva Co.
Toxicology · 109d