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510(k) Data Aggregation

    K Number
    K023867
    Device Name
    MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    2002-12-17

    (27 days)

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

    MAS® T-Marker Control is intended for use in the clinical laboratory as a quantitative. control for monitoring test procedures used to assay human serum for tumor markers. Include T-Marker Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

    DADE® Special-T Marker® Control is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum for tumor markers. Include Special-T Marker® Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a quality control material (MAS® T-Marker, Level 1, 2 and 3 and DADE® Special-T Marker®, Level 1, 2 and 3). It states that the device is "substantially equivalent" to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot extract the requested information from this document. The sections you asked for, such as a table of acceptance criteria and reported performance, sample sizes, ground truth details, expert qualifications, adjudication methods, or MRMC/standalone studies, are not present.

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