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510(k) Data Aggregation

    K Number
    K023763
    Device Name
    RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2003-01-13

    (66 days)

    Product Code
    LCP,JIT,JJX
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K042193,K131307,K170147
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fructosamine: The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma. Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks. For in vitro diagnostic use only. Fructosamine Calibrator: For calibration of the Fructosamine assay. For in vitro diagnostic use only. Fructosamine Controls (Level 1 and Level 3): To monitor the performance of the Fructosamine assay. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document primarily focuses on the substantial equivalence determination for the Fructosamine device. It does not include:

    • Acceptance criteria specified with numerical targets.
    • Detailed device performance data (e.g., accuracy, precision, sensitivity, specificity).
    • Information about specific studies conducted (e.g., sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies).

    Therefore, I cannot extract the information required to fulfill your request based on the given text.

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