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510(k) Data Aggregation

    K Number
    K040111
    Device Name
    ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    2004-04-05

    (76 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    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™ MPO/PR3 Test System is for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and/or human proteinase 3 (PR3) in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of systemic vasculitides (SV). This test is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification document for a medical device called the "AtheNA Multi-Lite™ MPO/ PR3 IgG Test System." This document primarily deals with the administrative and regulatory approval of the device, stating its substantial equivalence to previously marketed devices. It outlines the indications for use but does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, or ground truth establishment.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for the test set or data provenance details.
    • Number of experts and their qualifications for establishing ground truth.
    • Adjudication method.
    • Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This is an in vitro diagnostic test, not an AI-powered imaging device).
    • Details on standalone (algorithm only) performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document only states the device's indications for use: "The Zeus Scientific, Inc. AtheNA Multi-Lyte™ MPO/PR3 Test System is for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and/or human proteinase 3 (PR3) in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of systemic vasculitides (SV). This test is for in vitro diagnostic use."

    To obtain the information you're asking for, you would typically need to refer to the device's clinical study report or performance evaluation data, which are usually more detailed documents submitted as part of the 510(k) application but are not fully present in this summary letter.

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