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510(k) Data Aggregation

    K Number
    K033802
    Device Name
    ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    2004-02-27

    (81 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and quantitative detection of RF IgM class antibody in human serum. The test system is intended for the analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System and focuses on regulatory approval rather than detailed study design or acceptance criteria.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for test sets.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication methods.
    5. Information on MRMC comparative effectiveness studies.
    6. Details on standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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