Product Code: LCM FDA unclassified

Enzyme Immunoassay, Phencyclidine

Unknown

Enzyme immunoassay for phencyclidine (PCP) is a laboratory immunoassay test used to detect phencyclidine, a dissociative drug, in patient specimens for clinical toxicology screening or confirmation purposes. This device is currently unclassified by the FDA, with no assigned regulation number or medical specialty designation, meaning its regulatory requirements have not been definitively established. The product code is LCM. No special risk flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LCM
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 88 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K212952	Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair	Apr 18, 2022	Substantially Equivalent	Psychemedics Corporation
K203489	SEFRIA PCP Oral Fluid Enzyme Immunoassay	Apr 20, 2021	Substantially Equivalent	Immunalysis Corporation
K181135	Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay	Jan 24, 2019	Substantially Equivalent	Immunalysis Corporation
K163220	Atellica CH Phencyclidine (Pcp)	Apr 06, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K152176	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Sep 04, 2015	Substantially Equivalent	Immunalysis Corporation
K142044	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	Aug 25, 2014	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K131181	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE	Jun 25, 2013	Substantially Equivalent	Omega Laboratories, Inc.
K122703	RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR	Apr 25, 2013	Substantially Equivalent	Biophor Diagnostics, Inc.
K111928	PSYCHEMEDICS PHENCYCLIDINE EIA	May 01, 2012	Substantially Equivalent	Psychemedics Corp.
K101746	THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY	Apr 08, 2011	Substantially Equivalent	Microgenics Corp.
K093989	ORAL FLUID PHENCYCLIDINE	Jan 25, 2011	Substantially Equivalent	Roche Diagnostics
K101059	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE	Jul 12, 2010	Substantially Equivalent	Omega Laboratories, Inc.
K080431	RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054	Jan 08, 2009	Substantially Equivalent	Quantrx Biomedical Corporation
K062094	VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V	Nov 22, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K060353	ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000	May 03, 2006	Substantially Equivalent	Acro Biotech, LLC
K042726	QUEST DIAGNOSTICS HAIRCHECK-DT (PCP	Jul 28, 2005	Substantially Equivalent	Quest Diagnostics, Inc.
K043071	RANDOX PHENCYCLIDINE ASSAY	Jan 27, 2005	Substantially Equivalent	Randox Laboratories, Ltd.
K043305	ONLINE DAT PHENCYCLIDINE PLUS	Jan 10, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K041578	QUICKSCREEN, MODELS 9177X AND 9178X	Sep 10, 2004	Substantially Equivalent	Phamatech
K023109	AMEDICA DRUG SCREEN PHENCYCLIDINE TEST	Dec 16, 2002	Substantially Equivalent	Amedica Biotech, Inc.
K020254	PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011	May 10, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K013096	PHENCYCLIDINE	Mar 13, 2002	Substantially Equivalent	Abbott Laboratories
K012582	AMEDITECH IMMUTEST DRUG SCREEN PCP	Nov 30, 2001	Substantially Equivalent	Ameditech, Inc.
K011730	ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE	Aug 09, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K012107	LIVESURE PHENECYCLINE (PCP) SCREEN TESTS	Jul 20, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K010047	INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K010045	INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K011161	MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229	May 15, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K010651	AT HOME DRUG TEST, MODEL 9133 T	Mar 30, 2001	Substantially Equivalent	Phamatech
K002272	BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D	Nov 22, 2000	Substantially Equivalent	Branan Medical Corp.
K002776	MODIFICATION TO PROFILE -II	Sep 28, 2000	Substantially Equivalent	Medtox Diagnostics, Inc.
K000399	STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541	May 15, 2000	Substantially Equivalent	OraSure Technologies, Inc.
K000402	SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST	Apr 18, 2000	Substantially Equivalent	Drug Detection Devices, Ltd.
K000462	URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A	Apr 06, 2000	Substantially Equivalent	Dade Behring, Inc.
K994030	ONTRAK TESTCUP 5, CAT. 07 6481 7	Jan 27, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K994020	ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2	Jan 27, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K994017	ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1	Jan 27, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K993983	SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL	Jan 27, 2000	Substantially Equivalent	Syva Co.
K994236	AT HOME DRUG TEST, MODEL 9133	Dec 30, 1999	Substantially Equivalent	Phamatech
K993945	BIONIKE AQ PHENCYCLIDINE (PCP) TEST	Dec 07, 1999	Substantially Equivalent	Bionike Laboratories, Inc.
K991698	REDI-TEST PCP	Aug 25, 1999	Substantially Equivalent	Redwood Biotech, Inc.
K991505	MICRO-STRIP FOR PHENCYCLIDINE METABOLITES	Aug 05, 1999	Substantially Equivalent	Microdiagnostics, Inc.
K983790	VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE	Mar 01, 1999	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K981363	ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST	Dec 22, 1998	Substantially Equivalent	Tcpi, Inc.
K982801	AUTO-LYTE PCP EIA, MODEL #1254U	Nov 04, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K981292	QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST	May 26, 1998	Substantially Equivalent	Syntron Bioresearch, Inc.
K981019	QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST	May 07, 1998	Substantially Equivalent	Syntron Bioresearch, Inc.
K974582	QUICKSCREEN ONE STEP PCP SCREENING TEST	Feb 04, 1998	Substantially Equivalent	Phamatech
K972963	MODIFIED CEDIA DAU PCP ASSAY	Sep 22, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K964355	ONTRAK TESTCUP 5 (MODIFICATION)	Dec 13, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K963692	VERDICT PCP	Dec 10, 1996	Substantially Equivalent	Editek, Inc.
K963233	EZ-SCREEN PROFILE	Oct 31, 1996	Substantially Equivalent	Editek, Inc.
K961266	ACCUSIGN, BIOSIGN PCP	May 31, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K953534	AXSYM PHENCYCLIDINE II	Oct 26, 1995	Substantially Equivalent	Abbott Laboratories
K950183	URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE	Mar 20, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K935191	EMIT IIC PHENCYCLIDINE ASSAY	Feb 22, 1995	Substantially Equivalent	Syva Co.
K946059	CEDIA(R) DAU PCP ASSAY	Jan 17, 1995	Substantially Equivalent	Microgenics Corp.
K944605	CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM	Dec 07, 1994	Substantially Equivalent	Beckman-Diagnostic Systems Group
K943711	EZ-SCREEN:PCP	Sep 09, 1994	Substantially Equivalent	Editek, Inc.
K935629	USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400	Apr 12, 1994	Substantially Equivalent	U.S. Drug Testing, Inc.
K935650	CEDIA(R) DAU PCP ASSAY	Apr 05, 1994	Substantially Equivalent	Microgenics Corp.
K935320	PHENCYCLIDINE EIA ASSAY	Dec 29, 1993	Substantially Equivalent	Diagnostic Reagents, Inc.
K924751	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	Dec 11, 1992	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K924462	STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA	Nov 02, 1992	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K921651	MICROLINE SCREEN FOR PHENCYCLIDINE	Jul 08, 1992	Substantially Equivalent	Drug Screening Systems, Inc.
K920957	PHENCYCLIDINE EIA ASSAY, MODIFICATION	Mar 18, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K920935	ABUSCREEN ONLINE FOR PHENCYCLIDINE	Mar 18, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K915728	EMIT D.A.U. PHENCYCLIDINE ASSAY	Jan 27, 1992	Substantially Equivalent	Syva Co.
K915179	PHENCYCLIDINE EIA ASSAY	Dec 09, 1991	Substantially Equivalent	Diagnostic Reagents, Inc.
K913743	IL TEST(TM) PHENCYCLIDINE	Nov 07, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K911153	MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT	Jun 18, 1991	Substantially Equivalent	Immunotech Corp.
K911725	ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD	Jun 03, 1991	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K904765	EMIT (R) II PHENCYCLIDINE ASSAY	Nov 28, 1990	Substantially Equivalent	Syva Co.
K902960	MILENIA(TM) PCP	Aug 17, 1990	Substantially Equivalent	Diagnostic Products Corp.
K900921	HYCOR ACCUPINCH PHENCYCLIDINE TEST	Apr 26, 1990	Substantially Equivalent	Hycor Biomedical, Inc.
K900940	TDX PHENCYCLIDINE II ASSAY	Apr 25, 1990	Substantially Equivalent	Abbott Laboratories
K895906	ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)	Jan 26, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K890688	ADX TM PHENCYCLIDINE	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K874267	REVISED LABELING FOR PCP TEST KIT	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K873756	LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K854167	TDX PHENCYCLIDINE	Nov 05, 1985	Substantially Equivalent	Abbott Laboratories
K853548	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS	Sep 18, 1985	Substantially Equivalent	American Dade
K843509	EMIT 700 PHENCYCLIDINE ASSAY	Sep 27, 1984	Substantially Equivalent	Syva Co.
K840199	EMIT ST SERUM PHENCYCLIDINE ASSAY	Mar 22, 1984	Substantially Equivalent	Syva Co.
K840061	EMIT ST URINE PHENCYCLIDINE ASSAY	Mar 19, 1984	Substantially Equivalent	Syva Co.
K810601	EMIT-ST SERUM PHENCYCLIDINE ASSAY	Mar 17, 1981	Substantially Equivalent	Syva Co.
K810093	EMIT-ST PHENCYCLIDINE ASSAY	Feb 02, 1981	Substantially Equivalent	Syva Co.
K790401	PHENCYCLIDINE URINE ASSAY	Jun 15, 1979	Substantially Equivalent	Syva Co.