Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K071711
    Device Name
    ASCA-CHEK
    Manufacturer
    TECHLAB INC., CORPORATE RESEARCH CENTER
    Date Cleared
    2007-11-07

    (138 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The ASCA-CHEK test is an ELISA for the measurement of human anti-S. cerevisiae antibodies in feces and serum as an indicator of Crohn's disease in combination with other clinical and laboratory findings. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. For feces, a specimen dilution of 1:10 and an OD 450 cut-off ≥0.150 or OD450620 ≥0.110 are used for the analysis. For serum, a specimen dilution of 1:1000 and an OD450 cut-off ≥0.110 or OD450620 ≥0.080 are used for the analysis. When human ASCA is present in fecal or serum specimens, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal and serum ASCA is an indicator of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis and IBS. This diagnostic method offers a simple to perform assay that may be used with either fecal or serum specimens.
    Ask a Question
    K Number
    K051927
    Device Name
    TECHLAB ASCA-CHEK
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2006-04-06

    (262 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The TECHLAB® ASCA-CHEK test is an enzyme-linked immunoassay (ELISA) for the measurement of human anti-S. cerevisiae antibodies in feces as an aid in the diagnosis of Crohn's disease. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. When human ASCA is present in the fecal specimen, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal ASCA is an aid in the diagnosis of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis. This noninvasive diagnostic method is simple to perform and requires only a fecal specimen for the analysis.
    Ask a Question
    K Number
    K051492
    Device Name
    AESKULISA ASCA A
    Manufacturer
    AESKU.INC
    Date Cleared
    2005-11-14

    (161 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings. AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is an aid in the diagnosis of Crohn`s disease and should be used in conjunction with other serological tests and clinical findings.
    Device Description
    solid phase enzyme immunoassay (ELISA) employing purified mannan
    Ask a Question
    K Number
    K042579
    Device Name
    BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2005-07-28

    (309 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.
    Device Description
    Not Found
    Ask a Question
    K Number
    K032850
    Device Name
    IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2004-03-18

    (188 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
    Device Description
    An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
    Ask a Question
    K Number
    K032860
    Device Name
    IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2004-03-18

    (188 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
    Device Description
    An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum.
    Ask a Question
    K Number
    K000733
    Device Name
    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2001-05-21

    (441 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    DEN000007
    Device Name
    QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2000-08-16

    (29 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Why did this record match?
    Product Code :

    NBT

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

    Page 1 of 1