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510(k) Data Aggregation

    K Number
    K071712
    Device Name
    LEUKO EZ VUE
    Manufacturer
    TECHLAB INC., CORPORATE RESEARCH CENTER
    Date Cleared
    2007-12-04

    (165 days)

    Product Code
    DEG
    Regulation Number
    866.5570
    Why did this record match?
    Product Code :

    DEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The LEUKO EZ VUE™ test is a 10 minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared LEUKO-TEST assay. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles. The membrane cassette contains two stripes of immobilized antibodies. One stripe contains anti-lactoferrin antibodies. The other, representing a control stripe, contains anti-IgG antibodies. The diluted sample and gold conjugate migrate by capillary action when the sample is added to the well. If elevated lactoferrin is present in the sample, gold conjugate-lactoferrin complexes form and are captured by the immobilized anti-lactoferrin antibodies in the stripe. The lactoferrin-conjugate-antibody complexes appear as a single red line in the test portion of the Results window. In the control stripe, conjugate binds to the immobilized anti-IgG antibodies, demonstrating correct migration of the sample and conjugate along the membrane. The conjugate-anti-IgG antibodies appear as a single red line in the control portion of the Results window.
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    K Number
    K042071
    Device Name
    IBD-SCAN
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2004-10-20

    (79 days)

    Product Code
    DEG
    Regulation Number
    866.5570
    Why did this record match?
    Product Code :

    DEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBD-SCAN™ test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker of fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish messinal inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K030704
    Device Name
    IBD-QUIK CHEK
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2003-04-21

    (46 days)

    Product Code
    DEG
    Regulation Number
    866.5570
    Why did this record match?
    Product Code :

    DEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBD-QUIK CHEK™ test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The IBD-OUIK CHEKM test is a 10-minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared I.F.UKO-12ST® and IBD-CHEK™ test. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles.
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    K Number
    K011396
    Device Name
    IBD-CHEK
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2001-06-18

    (42 days)

    Product Code
    DEG
    Regulation Number
    866.5570
    Why did this record match?
    Product Code :

    DEG

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