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510(k) Data Aggregation

    K Number
    K143325
    Device Name
    OC-Light S FIT
    Manufacturer
    EIKEN CHEMICAL CO. LTD
    Date Cleared
    2015-08-20

    (273 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    EIKEN CHEMICAL CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is a qualitative test intended for the immunochemical detection of fecal occult blood (FOB) by professional laboratories and physician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI) bleeding may be suspected. OC-Light S FIT is recommended for use in routine physical examinations.
    Device Description
    OC-Light S FIT is an in vitro diagnostic device, a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. OC-Light S FIT consists of a test strip, and a sampling bottle containing buffer solution. OC-Light S FIT test strip consists of a nitrocellulose membrane with immobilized mouse monoclonal antibodies specific to human hemoglobin at the test region and immobilized rabbit anti-mouse antibodies at the control region, a sample pad, a conjugate pad which contains human hemoglobin specific mouse monoclonal antibodies conjugated with colloidal gold, an absorption pad, and a plastic backing. OC-Light S FIT sampling bottle is a plastic bottle for collecting fecal sample containing 2.0 mL of extraction buffer. When the sample end of the test strip is dipped in the fecal extract, the liquid fecal extract wicks through a series of absorbent materials and contacts colloidal gold conjugated with monoclonal antibodies specific to hHb. If hHb is present in the sample, it reacts with the antibodies on the colloidal gold. When the gold conjugate with hHb reaches the test region of the membrane, it binds with the immobilized antibodies also specific to hHb to form a visible reddish/pink line. The procedural control region of the membrane contains immobilized anti-mouse antibodies that capture the conjugate independent of the presence of the hHb, thereby always producing a distinct reddish/pink line. The reddish/pink line in the procedural control region demonstrates the validity of the test, and assures the operator that the device is working properly.
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