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510(k) Data Aggregation

    K Number
    K023856
    Device Name
    VISUALINE METHADONE DIPSTRIPTEST
    Date Cleared
    2003-08-25

    (279 days)

    Product Code
    Regulation Number
    862.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.
    Device Description
    The Visualine® Methadone DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Methadone and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site. A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.
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    K Number
    K023648
    Device Name
    VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
    Date Cleared
    2003-05-06

    (188 days)

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

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Visualine®Cup VI for Drugs of Abuse Test is used for qualitative testing for the presence of Cocaine and it's metabolites at or above 300 ng/ml, Cannabinoids and it's metabolites at or above 50 ng/ml, Morphine and it's metabolites at or above 300 ng/ml, Methamphetamine at or above 1,000 ng/ml, Amphetamine at or above 1,000 ng/ml, Phencyclidine at or above 25 ng/ml, and Benzodiazepines and it's metabolites at or above 300 ng/ml in human urine samples. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result.
    Device Description
    The Visualine® CupVI for Drugs of Abuse Test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine or Amphetamines, Phencyclidine, and Benzodiazepines and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the test panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site. A reference or control line with a secondary antibody reaction is added to the membrane strip to check for proper sample migration on the membrane. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.
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    K Number
    K014089
    Device Name
    VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
    Date Cleared
    2002-04-25

    (135 days)

    Product Code
    Regulation Number
    862.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Visualine®II (SunLine®) Barbiturates Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.
    Device Description
    Not Found
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    K Number
    K020136
    Device Name
    VISUALINE BARBITURATES DIPSTRIP TEST
    Date Cleared
    2002-03-20

    (64 days)

    Product Code
    Regulation Number
    862.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Visualine® Barbiturates DipStrip Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.
    Device Description
    The Visualine® Barbiturates DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Barbiturates and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site. A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.
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    K Number
    K011499
    Device Name
    VISUALINE AMPHETAMINE DIPSTRIP ASSAY
    Date Cleared
    2001-07-17

    (63 days)

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

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K010177
    Device Name
    VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
    Date Cleared
    2001-05-17

    (119 days)

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

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993485
    Device Name
    VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
    Date Cleared
    1999-12-27

    (74 days)

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

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.
    Device Description
    The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.
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    K Number
    K983790
    Device Name
    VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
    Date Cleared
    1999-03-01

    (125 days)

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

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Visualine® II Assay is used for qualitative testing for the presence of Phencyclidine in urine.
    Device Description
    Not Found
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    K Number
    K981314
    Device Name
    VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
    Date Cleared
    1998-09-04

    (147 days)

    Product Code
    Regulation Number
    862.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Qualitative visual test for the presence of Methadone and its metabolites in urine samples.
    Device Description
    Visualine II (Also Known As SunLine) Methadone
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    K Number
    K972032
    Device Name
    VISUALINE II METHAMPHETIMINE
    Date Cleared
    1997-08-12

    (71 days)

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

    SUN BIOMEDICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Qualitative visual teit for the presence of Methliam phetamine and its metabolites in Uside sample
    Device Description
    Not Found
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