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510(k) Data Aggregation

    K Number
    K061065
    Device Name
    FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2006-07-14

    (88 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

    Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physicians offices. It is useful to determining gastrointestinal bleeding found in a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis. Teco Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

    Device Description

    Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for the Teco Rapid Fecal Occult Blood (FOB) Card Test. It confirms substantial equivalence to a predicate device but does not contain the detailed study information required to answer the questions about acceptance criteria and device performance. The letter refers to an "enclosure" for the indications for use, and a subsequent page in the document does provide the indications for use, but still, no study details are present.

    Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory approval letter, not a scientific study report.

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