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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    ADVANTAGE DIAGNOSTICS CORP.

    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
    K011962
    Device Name
    ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
    Date Cleared
    2001-08-09

    (48 days)

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

    ADVANTAGE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Advantage Marijuana (THC) and Cocaine Home Drug Test is designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL and Cocaine metabolites at a cut off of 300ng/mL. The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of THC and /or Cocaine in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
    Device Description
    The Advantage Marijuana (THC) and Cocaine Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
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    K Number
    K010921
    Device Name
    ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
    Date Cleared
    2001-06-25

    (90 days)

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

    ADVANTAGE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K003708
    Device Name
    ADVANTAGE THC/COCAINE TEST
    Date Cleared
    2001-01-22

    (52 days)

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

    ADVANTAGE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K001567
    Device Name
    ADVANTAGE THC TEST
    Date Cleared
    2000-06-19

    (31 days)

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

    ADVANTAGE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K994227
    Device Name
    ADVANTAGE HCG TEST (URINE/SERUM)
    Date Cleared
    2000-02-03

    (50 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANTAGE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Advantage hCG Test (Urine/Serum) is a qualitative, rapid immunochromatographic assay used to detect the presence of hCG in human urine and serum for the early detection of pregnancy. The test is intended for use in clinical laboratories by health care professionals.
    Device Description
    The Advantage hCG Test (Urine/Serum) is an immunochromatographic based one step in vitro test.
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    K Number
    K991883
    Device Name
    REDI-TEST OPIATES
    Date Cleared
    1999-09-15

    (105 days)

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

    ADVANTAGE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of the opiate compounds including morphine at a cut off concentration of 300 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
    Device Description
    The Redi-Test Opiates is an immunochromatograpic based one step in vitro test.
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