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510(k) Data Aggregation

    K Number
    K040327
    Device Name
    ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
    Date Cleared
    2004-04-19

    (69 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided. The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
    Device Description
    The Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana or cocaine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine antibodies and therefore the colored line will not form in the test region. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
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    K Number
    K030447
    Device Name
    AT HOME DRUG CUP, MODEL 9150X
    Manufacturer
    Date Cleared
    2003-04-14

    (62 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.
    Device Description
    The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Cup, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / complexes.
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    K Number
    K014192
    Device Name
    LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
    Date Cleared
    2002-05-23

    (153 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
    Device Description
    Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine. Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
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    K Number
    K013778
    Device Name
    PEACE OF MIND HOME DRUG TEST
    Date Cleared
    2002-02-07

    (86 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations: | THC | 50ng/mL | |-----------------|-----------| | PCP | 25ng/mL | | Opiates | 2000ng/mL | | Cocaine | 300ng/mL | | Methamphetamine | 1000ng/mL | The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step. The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations: | THC | 50ng/mL | |-----------------|-----------| | РСР | 25ng/mL | | Opiates | 2000ng/mL | | Cocaine | 300ng/mL | | Methamphetamine | 1000ng/mL | The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
    Device Description
    The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
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    K Number
    K013409
    Device Name
    AT HOME DRUG TEST, MODEL 9074
    Manufacturer
    Date Cleared
    2001-12-06

    (52 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of the following drugs of abuse in urine: Cocaine.
    Device Description
    Immunoassay for the qualitative detection of benzoylecgonine in urine. The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: cocaine; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
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    K Number
    K013410
    Device Name
    AT HOME DRUG TEST, MODEL 9064
    Manufacturer
    Date Cleared
    2001-12-06

    (52 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection/presence of the following drugs of abuse in urine: Amphetamines.
    Device Description
    Immunoassay for the qualitative detection of Amphetamines in urine. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
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    K Number
    K013412
    Device Name
    AT HOME DRUG TEST, MODEL 9069
    Manufacturer
    Date Cleared
    2001-12-06

    (52 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of any of the following drugs of abuse in urine: Methamphetamine, MDMA.
    Device Description
    The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: Methamphetamine, MDMA; 500 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.
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    K Number
    K010653
    Device Name
    AT HOME DRUG TEST, MODEL 9068 T
    Manufacturer
    Date Cleared
    2001-04-05

    (31 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K010654
    Device Name
    AT HOME DRUG TEST, MODEL 9078 T
    Manufacturer
    Date Cleared
    2001-04-05

    (31 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K010655
    Device Name
    AT HOME DRUG TESTT, MODEL 9150 T
    Manufacturer
    Date Cleared
    2001-04-05

    (31 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MVO

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