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510(k) Data Aggregation

    K Number
    K984319
    Device Name
    ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-12-22

    (19 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K950469
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Architect Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay on the Abbott Architect i System.

    Device Description

    Architect Free T3 MasterCheck Level 0 contains human serum. Architect Free T3 MasterCheck Levels 1, 2 and 3 contain Free T3 prepared in human serum. Preservative: Sodium Azide.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the "Architect Free T3 MasterCheck" device, primarily focused on establishing its substantial equivalence to a predicate device.

    It details:

    • The device's intended use.
    • A comparison of technological characteristics with a predicate device.
    • Confirmation from the FDA regarding its classification and clearance.

    However, there is no mention of:

    1. Specific acceptance criteria (like accuracy, precision, sensitivity, specificity thresholds).
    2. Any performance study involving a test set, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
    3. Standalone algorithm performance or multi-reader multi-case studies, as this device is a control/calibrator, not an AI-driven diagnostic.
    4. Training set information, as it's not an AI/machine learning device.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study from the given input.

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