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510(k) Data Aggregation

    K Number
    K962594
    Device Name
    ACA PLUS FT4 CALIBRATOR
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1996-08-15

    (44 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The aca® plus FT4 Calibrator is intended to be used on the aca® plus immunoassay system to calibrate the Free Thyroxine (FT4) Method.

    Device Description

    The FT4 Calibrator is a lyophilized human serum-based product. The Level 1 calibrator contains no detectable thyroxine. The kit consists of six vials two at each of three levels.

    AI/ML Overview

    The provided document is a summary of safety and effectiveness information for a medical device called "aca® plus FT4 Calibrator". This document does not describe an AI device or a study involving an AI algorithm evaluating performance against acceptance criteria.

    Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable to the content of this document. This document pertains to a laboratory calibrator and its comparison to a predicate device, not an AI efficacy study.

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