Enzyme Immunoassay, Phencyclidine
FDA product code LCM · Unclassified · Clinical Toxicology
88510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Syva Co. 10
- Roche Diagnostics Corp. 5
- Abbott Laboratories 5
- Roche Diagnostic Systems, Inc. 4
- Phamatech 4
- Diagnostic Reagents, Inc. 3
- Editek, Inc. 3
- Microgenics Corp. 3
- Immunalysis Corporation 3
- Psychemedics Corp. 2
- Syntron Bioresearch, Inc. 2
- Solarcare Technologies Corp,Inc. 2
- E.I. Dupont DE Nemours & Co., Inc. 2
- Diagnostic Products Corp. 2
- Omega Laboratories, Inc. 2
- Alfa Scientific Designs, Inc. 2
- OraSure Technologies, Inc. 2
- Drug Screening Systems, Inc. 1
- Siemens Healthcare Diagnostics, Inc. 1
- Immunotech Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairLCM · Traditional | Psychemedics Corporation | 04/18/2022SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | Immunalysis Corporation | 04/20/2021SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | Immunalysis Corporation | 01/24/2019SE |
| K163220 | Atellica CH Phencyclidine (Pcp)LCM · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/06/2017SE |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM · Traditional | Immunalysis Corporation | 09/04/2015SE |
| K142044 | CR3 Keyless Split Sample Cup Phencyclidien - MethylenedioxymethamphetamineLCM · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 08/25/2014SE |
| K131181 | Omega Laboratories Hair Drug Screening Assay PhencyclidineLCM · Traditional | Omega Laboratories, Inc. | 06/25/2013SE |
| K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…LCM · Traditional | Biophor Diagnostics, Inc. | 04/25/2013SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayLCM · Traditional | Microgenics Corp. | 04/08/2011SE |
| K093989 | Oral Fluid PhencyclidineLCM · Traditional | Roche Diagnostics | 01/25/2011SE |
| K101059 | Omega Laboratories Hair Drug Screening Assay for PhencyclidineLCM · Traditional | Omega Laboratories, Inc. | 07/12/2010SE |
| K080431 | Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054LCM · Traditional | Quantrx Biomedical Corporation | 01/08/2009SE |
| K062094 | Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat…LCM · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/22/2006SE |
| K060353 | Acro Rapid Phencyclidine Urine Test, Catalog PCP001000LCM · Traditional | Acro Biotech, LLC | 05/03/2006SE |
| K042726 | Quest Diagnostics Haircheck-Dt (PCPLCM · Traditional | Quest Diagnostics, Inc. | 07/28/2005SE |
| K043071 | Randox Phencyclidine AssayLCM · Traditional | Randox Laboratories, Ltd. | 01/27/2005SE |
| K043305 | Online Dat Phencyclidine PlusLCM · Traditional | Roche Diagnostics Corp. | 01/10/2005SE |
| K041578 | Quickscreen, Models 9177X and 9178XLCM · Special | Phamatech | 09/10/2004SE |
| K023109 | Amedica Drug Screen Phencyclidine TestLCM · Traditional | Amedica Biotech, Inc. | 12/16/2002SE |
| K020254 | Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011LCM · Traditional | Lin-Zhi International, Inc. | 05/10/2002SE |
| K013096 | PhencyclidineLCM · Traditional | Abbott Laboratories | 03/13/2002SE |
| K012582 | Ameditech Immutest Drug Screen PCPLCM · Traditional | Ameditech, Inc. | 11/30/2001SE |
| K011730 | Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test DeviceLCM · Traditional | ACON Laboratories, Inc. | 08/09/2001SE |
| K012107 | Livesure Phenecycline (PCP) Screen TestsLCM · Traditional | Pan Probe Biotech, Inc. | 07/20/2001SE |
| K010047 | Instant-View Phencyclidine (PCP) Urine Cassette TestLCM · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K010045 | Instant-View Phencyclidine (PCP) Urine Dip Strip TestLCM · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | Syva Co., Dade Behring, Inc. | 05/15/2001SE |
| K010651 | At Home Drug Test, Model 9133 TLCM · Special | Phamatech | 03/30/2001SE |
| K002272 | Branan Medical Corporation Monitect PCP Drug Screen Test, Model 160C and 160DLCM · Traditional | Branan Medical Corp. | 11/22/2000SE |
| K002776 | Modification to Profile -IiLCM · Special | Medtox Diagnostics, Inc. | 09/28/2000SE |
| K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541LCM · Traditional | OraSure Technologies, Inc. | 05/15/2000SE |
| K000402 | Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) TestLCM · Traditional | Drug Detection Devices, Ltd. | 04/18/2000SE |
| K000462 | Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog No. DF 94ALCM · Traditional | Dade Behring, Inc. | 04/06/2000SE |
| K994030 | Ontrak Testcup 5, Cat. 07 6481 7LCM · Traditional | Roche Diagnostics Corp. | 01/27/2000SE |
| K994020 | Ontrak Teststik for PCP, Cat. 07 6654 2LCM · Traditional | Roche Diagnostics Corp. | 01/27/2000SE |
| K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1LCM · Traditional | Roche Diagnostics Corp. | 01/27/2000SE |
| K993983 | Syva Emit II Plus Phencyclidine Assay, Model 9J029ULLCM · Traditional | Syva Co. | 01/27/2000SE |
| K994236 | At Home Drug Test, Model 9133LCM · Special | Phamatech | 12/30/1999SE |
| K993945 | Bionike Aq Phencyclidine (PCP) TestLCM · Traditional | Bionike Laboratories, Inc. | 12/07/1999SE |
| K991698 | Redi-Test PCPLCM · Traditional | Redwood Biotech, Inc. | 08/25/1999SE |
| K991505 | Micro-Strip for Phencyclidine MetabolitesLCM · Traditional | Microdiagnostics, Inc. | 08/05/1999SE |
| K983790 | Visualine II (Also Known AS Sunline) PhencyclidineLCM · Traditional | Sun Biomedical Laboratories, Inc. | 03/01/1999SE |
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | Tcpi, Inc. | 12/22/1998SE |
| K982801 | Auto-Lyte PCP Eia, Model #1254ULCM · Traditional | OraSure Technologies, Inc. | 11/04/1998SE |
| K981292 | Quikpac II One Step Phencyclidine (PCP) TestLCM · Traditional | Syntron Bioresearch, Inc. | 05/26/1998SE |
| K981019 | Quikstrip One Step Phencyclidine (PCP) TestLCM · Traditional | Syntron Bioresearch, Inc. | 05/07/1998SE |
| K974582 | Quickscreen One Step PCP Screening TestLCM · Traditional | Phamatech | 02/04/1998SE |
| K972963 | Modified Cedia Dau PCP AssayLCM · Traditional | Boehringer Mannheim Corp. | 09/22/1997SE |
| K964355 | Ontrak Testcup 5 (Modification)LCM · Traditional | Roche Diagnostic Systems, Inc. | 12/13/1996SE |
| K963692 | Verdict PCPLCM · Traditional | Editek, Inc. | 12/10/1996SE |
| K963233 | Ez-Screen ProfileLCM · Traditional | Editek, Inc. | 10/31/1996SE |
| K961266 | Accusign, Biosign PCPLCM · Traditional | Princeton BioMeditech Corp. | 05/31/1996SE |
| K953534 | Axsym Phencyclidine IILCM · Traditional | Abbott Laboratories | 10/26/1995SE |
| K950183 | Urine Phencyclidine Screen Flex(Tm) Reagent CartridgeLCM · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/20/1995SE |
| K935191 | Emit Iic Phencyclidine AssayLCM · Traditional | Syva Co. | 02/22/1995SE |
| K946059 | Cedia(R) Dau PCP AssayLCM · Traditional | Microgenics Corp. | 01/17/1995SE |
| K944605 | CX Phencyclidine Reagent for Synschron CX SystemLCM · Traditional | Beckman-Diagnostic Systems Group | 12/07/1994SE |
| K943711 | Ez-Screen:PcpLCM · Traditional | Editek, Inc. | 09/09/1994SE |
| K935629 | Usdt Phencyclidine (PCP) Assay Column Cat. No. 9000-400LCM · Traditional | U.S. Drug Testing, Inc. | 04/12/1994SE |
| K935650 | Cedia(R) Dau PCP AssayLCM · Traditional | Microgenics Corp. | 04/05/1994SE |
| K935320 | Phencyclidine Eia AssayLCM · Traditional | Diagnostic Reagents, Inc. | 12/29/1993SE |
| K924751 | Solarcare Technologies Corp. Micro-Plate PCP AssayLCM · Traditional | Solarcare Technologies Corp,Inc. | 12/11/1992SE |
| K924462 | STC Diagnostics Auto-Lyte(Tm) PCP EiaLCM · Traditional | Solarcare Technologies Corp,Inc. | 11/02/1992SE |
| K921651 | Microline Screen for PhencyclidineLCM · Traditional | Drug Screening Systems, Inc. | 07/08/1992SE |
| K920957 | Phencyclidine Eia Assay, ModificationLCM · Traditional | Diagnostic Reagents, Inc. | 03/18/1992SE |
| K920935 | Abuscreen Online for PhencyclidineLCM · Traditional | Roche Diagnostic Systems, Inc. | 03/18/1992SE |
| K915728 | Emit D.A.U. Phencyclidine AssayLCM · Traditional | Syva Co. | 01/27/1992SE |
| K915179 | Phencyclidine Eia AssayLCM · Traditional | Diagnostic Reagents, Inc. | 12/09/1991SE |
| K913743 | Il Test(Tm) PhencyclidineLCM · Traditional | Instrumentation Laboratory CO | 11/07/1991SE |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test KTLCM · Traditional | Immunotech Corp. | 06/18/1991SE |
| K911725 | Aca(R) Urine Phencyclidine (U PCP) Screen MethodLCM · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/03/1991SE |
| K904765 | Emit (R) II Phencyclidine AssayLCM · Traditional | Syva Co. | 11/28/1990SE |
| K902960 | Milenia(Tm) PCPLCM · Traditional | Diagnostic Products Corp. | 08/17/1990SE |
| K900921 | Hycor Accupinch Phencyclidine TestLCM · Traditional | Hycor Biomedical, Inc. | 04/26/1990SE |
| K900940 | TDX Phencyclidine II AssayLCM · Traditional | Abbott Laboratories | 04/25/1990SE |
| K895906 | Abuscreen Ontrak for Phencyclidine (PCP)LCM · Traditional | Roche Diagnostic Systems, Inc. | 01/26/1990SE |
| K890688 | Adx TM PhencyclidineLCM · Traditional | Abbott Laboratories | 08/25/1989SE |
| K874267 | Revised Labeling for PCP Test KitLCM · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K873756 | Labeling Change PCP (Phencyclidine) in UrineLCM · Traditional | Diagnostic Products Corp. | 10/15/1987SE |
| K854167 | TDX PhencyclidineLCM · Traditional | Abbott Laboratories | 11/05/1985SE |
| K853548 | Stratus Procainamide Fluorometric Enzyme ImmunoassLCM · Traditional | American Dade | 09/18/1985SE |
| K843509 | Emit 700 Phencyclidine AssayLCM · Traditional | Syva Co. | 09/27/1984SE |
| K840199 | Emit ST Serum Phencyclidine AssayLCM · Traditional | Syva Co. | 03/22/1984SE |
| K840061 | Emit ST Urine Phencyclidine AssayLCM · Traditional | Syva Co. | 03/19/1984SE |
| K810601 | Emit-St Serum Phencyclidine AssayLCM · Traditional | Syva Co. | 03/17/1981SE |
| K810093 | Emit-St Phencyclidine AssayLCM · Traditional | Syva Co. | 02/02/1981SE |
| K790401 | Phencyclidine Urine AssayLCM · Traditional | Syva Co. | 06/15/1979SE |