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510(k) Data Aggregation

    K Number
    K052598
    Device Name
    IMMOCARE
    Manufacturer
    CARE DIAGNOSTIC, INC.
    Date Cleared
    2006-03-16

    (176 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens. It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

    ImmoCARE® is an immunological test for both professional and over the counter use..

    Device Description

    The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens.

    AI/ML Overview

    This is a letter from the FDA to a medical device manufacturer, Care Diagnostic, Inc., regarding their ImmoCARE® device. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. The letter does not contain information about acceptance criteria or performance studies. Therefore, I cannot provide the requested information.

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