LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K132195
    Device Name
    EUROIMMUN ANTI-PLA2R ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2014-06-27

    (347 days)

    Product Code
    PGV
    Regulation Number
    866.5780
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K132379
    Why did this record match?
    Device Name :

    EUROIMMUN ANTI-PLA2R ELISA (IGG)

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

    The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.

    Device Description

    The EUROIMMUN Anti-PLA2R ELISA (IgG) consists of a microwell ELISA plate coated with PLA2R antigen, 5 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

    AI/ML Overview

    The acceptance criteria and study proving the device meets them are detailed below for the EUROIMMUN Anti-PLA2R ELISA (IgG).

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance CriteriaReported Device Performance
    Reproducibility
    Intra-Assay CV
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1