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510(k) Data Aggregation

    K Number
    K080381
    Device Name
    QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2008-06-25

    (133 days)

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

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml. The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the determination of values in the measurement of methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device. The Ouest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
    Device Description
    Quest Diagnostics Methamphetamine Micro-Plate EIA is a solid phase competitive enzyme immunoassay for the detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device.
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    K Number
    K062929
    Device Name
    QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2006-12-18

    (81 days)

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

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 ng/ml and 150 ng/ml of benzoylecgonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use. The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoylecgonine in urine. The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine.
    Device Description
    Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the determination of cocaine metabolites in urine specimens.
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    K Number
    K051161
    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2005-11-22

    (201 days)

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

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) is a test system that utilizes the IDS Que-Step ELISA MDMA/Methamphetamine Kit for the qualitative detection of amphetamines at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic methamphetamine use and use of MDMA. This test system has not been evaluated for use with other populations or with hair specimens other than head. It is an in vitro diagnostic device intended exclusively for inhouse professional use only and not intended for sale to anyone. The QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
    Device Description
    Not Found
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    K Number
    K042726
    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2005-07-28

    (300 days)

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

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quest Diagnostics Hair Check-DT (PCP) is a test system that utilizes the IDS The Quest Diaghoutes Kit for the qualitative detection of Phencyclidine at or above 300 pg/mg in head hair samples. This test system has not been evaluated for use in specific user populations or with hair specimens other than the head. It is an in vitro spoorne asor populations exclusively for in-house professional use only and is not intended for sale to anyone. The Quest Diagnostics Hair Check-DT (PCP) screening test provides only a I ne Quest Diaghesate ist result. A more specific alternate chemical method must be prominal J analynour a confirmed result. Gas Chromatograph - Mass Spectrometry used in order to obtain a ion monitoring (SIM) mode is the preferred method with operating in the serected inter chemical confirmation methods are available. deateration interiation and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
    Device Description
    Not Found
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    K Number
    K042725
    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2005-07-06

    (278 days)

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

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users. This test system has not been evaluated for use with other user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for sale to anyone
    Device Description
    The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users.
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    K Number
    K040257
    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2004-06-14

    (131 days)

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

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens for the purpose of identifying chronic marijuana use. This process is intended exclusively for in-house professional use only. The process has not been evaluated for use with hair specimens other than head. Clinical consideration and professional judgement should be applied to any drug of abuse test result.
    Device Description
    The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens.
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    K Number
    K023626
    Device Name
    AML HAIRCHECK-DT (COCAINE)
    Manufacturer
    QUEST DIAGNOSTICS, INC.
    Date Cleared
    2003-09-29

    (335 days)

    Product Code
    DIO, DIF, DLJ
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUEST DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AML HairCheck-DT (Cocaine) is a process that utilizes the IDS One-Step ELISA Cocaine Kit in which head hair samples undergo forensic testing for the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This process is intended exclusively for in-house professional use only. The process is not intended for sale to anyone. The AML HairCheck-DT (Cocaine) provides only a preliminary analytical test result. For a quantitative analytical result or for confirmation, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in the selected ion monitoring mode using the deuterated internal standards. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
    Device Description
    Not Found
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