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510(k) Data Aggregation

    K Number
    K060700
    Device Name
    EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2006-09-08

    (177 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This test kit is designed for the determination of anti-proteinase 3 antibodies (PR3) in human serum and plasma. This test is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

    This test kit is designed for the determination of anti-myeloperoxidase antibodies (MPO) in human serum and plasma. This test is used as an aid in the differential diagnosis of microscopic polyangitis, Churg-Strauss syndrome and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and study details. The document is a 510(k) clearance letter from the FDA for two ELISA test kits (EUROIMMUN anti-Proteinase 3 (PR3) ELISA IgG and EUROIMMUN anti-Myeloperoxidase (MPO) ELISA IgG).

    It confirms the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not include:

    • A table of acceptance criteria and reported device performance. This kind of data is typically found in the 510(k) submission itself, not the clearance letter.
    • Sample size and data provenance for the test set.
    • Details on experts used for ground truth or adjudication methods.
    • Information about multi-reader multi-case studies or standalone algorithm performance. This is an IVD device, not an AI-powered diagnostic device, so these specific details are not applicable.
    • Type of ground truth used. While the indications mention "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth for the study is not described.
    • Sample size for the training set or how its ground truth was established. This refers to machine learning models, which are not relevant for this type of ELISA test kit.

    To obtain the information you're looking for, you would generally need to review the full 510(k) submission document, which often includes detailed study designs, performance data, and other technical information. The clearance letter acts as the FDA's confirmation of marketability based on that submission.

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