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510(k) Data Aggregation

    K Number
    K130811
    Device Name
    PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2013-05-02

    (38 days)

    Product Code
    DKZ, DEV
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Amphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories. The Psychemedics Microplate EIA amphetamine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Amphetamine. The screening portion of the test system consists of ( 1 ) microplate wells coated with multiple antigens including methamphetamine conjugated to bovine serum albumin (BSA), monoclonal mouse anti-amphetamine, rabbit anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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    K Number
    K123799
    Device Name
    PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2013-02-08

    (60 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Oxycodone is an enzyme immunoassay (EIA) for the preliminary qualitative detection of the opiate oxycodone in human head and body hair using an oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying oxycodone use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics Microplate EIA oxycodone assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Oxycodone. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including oxycodone conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-oxycodone, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (which stops the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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    K Number
    K111925
    Device Name
    PSYCHEMEDICS COCAINE EIA
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2012-05-01

    (300 days)

    Product Code
    JXO, DEV
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine in human head and body hair samples using a cocaine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use only and not for sale to anyone. The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.
    Device Description
    The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Cocaine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215). The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including benzoylecgonine conjugated to bovine serum albumin (BSA) (patent pending), monoclonal mouse anti-cocaine, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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    K Number
    K111926
    Device Name
    PSYCHEMEDICS OPIATES EIA
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2012-05-01

    (300 days)

    Product Code
    DJG, DEV
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics Microplate EIA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Opiates. The drug is recovered from the hair using a patented method (U.S. Patent #8,084.215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including morphine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-morphine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)}, HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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    K Number
    K111927
    Device Name
    PSYCHEMEDICS METHAMPHETAMINE EIA
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2012-05-01

    (300 days)

    Product Code
    LAF, DEV
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for inhouse professional use only and is not for sale to anyone. The Psychemedics Microplate EIA for Methamphetamine in Hair provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment must be applied to the interpretation of any drug-of-abuse test result.
    Device Description
    The test consists of two parts: a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Methamphetamine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including methamphetamine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-methamphetamine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCI to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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    K Number
    K111928
    Device Name
    PSYCHEMEDICS PHENCYCLIDINE EIA
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2012-05-01

    (300 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics EIA Phencyclidine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.
    Device Description
    The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Phencyclidine. The drug is recovered from the hair using a patented method (U.S. Patent #8.084.215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including phencyclidine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-phencyclidine, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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    K Number
    K111929
    Device Name
    PSYCHEMEDICS CANNABINOIDS EIA
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2012-05-01

    (300 days)

    Product Code
    LDJ, DEV
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11-nor-9-Carboxy- Δ'-THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics Chemiluminscent Microplate EIA for Cannabinoids assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The EIA screening test consists of two parts; a pre-analytical hair treatment procedure to recover the cannabinoids from the hair and the screening assay, the Psychemedics Chemiluminescent EIA for Cannabinoids in Hair. The device comprises a white microplate coated with the antigen (11-nor-9-carboxy-delta-8-tetrahydrocannabinol) conjugated to BSA, polyclonal rabbit anticannabinoid antibody, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), a chemiluminescent substrate, and platewashing buffer.
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    K Number
    K011426
    Device Name
    PSYCHEMEDICS RIA CANNABINOID ASSAY
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2002-05-03

    (360 days)

    Product Code
    LAT
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011275
    Device Name
    PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2002-02-11

    (291 days)

    Product Code
    LCL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011185
    Device Name
    PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
    Manufacturer
    PSYCHEMEDICS CORP.
    Date Cleared
    2002-01-24

    (281 days)

    Product Code
    DJC
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSYCHEMEDICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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