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
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Enzyme Immunoassay, Phencyclidine Devices (Product Code LCM)

88 devices
1–24 of 88
Cleared Apr 18, 2022
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952
Psychemedics Corporation
Toxicology · 214d
Cleared Apr 20, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489
Immunalysis Corporation
Toxicology · 144d
Cleared Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135
Immunalysis Corporation
Toxicology · 269d
Cleared Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
K163220
Siemens Healthcare Diagnostics, Inc.
Toxicology · 141d
Cleared Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176
Immunalysis Corporation
Toxicology · 31d
Cleared Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
K043305
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Mar 13, 2002
PHENCYCLIDINE
K013096
Abbott Laboratories
Toxicology · 177d
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 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 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 Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
K920935
Roche Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Jan 27, 1992
EMIT D.A.U. PHENCYCLIDINE ASSAY
K915728
Syva Co.
Chemistry · 38d
Cleared Nov 07, 1991
IL TEST(TM) PHENCYCLIDINE
K913743
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Jun 03, 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
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 25, 1990
TDX PHENCYCLIDINE II ASSAY
K900940
Abbott Laboratories
Toxicology · 56d

About Product Code LCM - Regulatory Context

510(k) Submission Activity

88 total 510(k) submissions under product code LCM since 1979, with 88 receiving FDA clearance (average review time: 97 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.