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510(k) Data Aggregation

    K Number
    K042071
    Device Name
    IBD-SCAN
    Manufacturer
    TECHLAB, INC.
    Date Cleared
    2004-10-20

    (79 days)

    Product Code
    DEG
    Regulation Number
    866.5570
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IBD-SCAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the IBD-SCANTM device. It acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    Therefore, I cannot provide the requested information based on the input text. The text only confirms the device's regulatory clearance and its intended use as an in vitro diagnostic aid for distinguishing inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS) by measuring fecal lactoferrin.

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