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510(k) Data Aggregation

    K Number
    K101831
    Device Name
    ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
    Manufacturer
    BIONOSTICS, INC.
    Date Cleared
    2010-10-01

    (92 days)

    Product Code
    OSL
    Regulation Number
    864.6550
    Why did this record match?
    Product Code :

    OSL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.
    Device Description
    Enterix InSure FIT FOBT Controls is a two-level, aqueous control solution. Enterix InSure FIT FOBT Controls is intended for use to verify the performance of Enterix InSure FIT product. The Enterix InSure FIT Test method is based on the detection of human hemoglobin (hHb). Human hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the hHb molecule. Because globin does not survive passage through the upper gastrointestinal (GI) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. Enterix InSure FIT FOBT Controls is a non-hazardous aqueous solution containing bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.
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