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510(k) Data Aggregation

    K Number
    K981493
    Device Name
    MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    1998-07-22

    (86 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the MTM Bioscanner C Test Strips. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter primarily covers:

    • Confirmation of substantial equivalence to a predicate device.
    • Regulatory classification (Class I).
    • Applicability of general controls provisions of the Act.
    • Instructions regarding CLIA complexity categorization.
    • Contact information for labeling, promotion, and general responsibilities.
    • The intended use of the device: "in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease."

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study details as they are not present in the provided text.

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