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510(k) Data Aggregation

    K Number
    K141827
    Device Name
    EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
    Manufacturer
    EUROIMMUN U.S., Inc.
    Date Cleared
    2015-04-17

    (284 days)

    Product Code
    DHN,PIV
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN U.S., Inc.

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

    Instrument: The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides. The EUROPattern Microscope and Software can only be used with cleared or approved EUROIMMUN in vitro diagnostic assays that are indicated for use on the device. All suggested results obtained with the EUROPattern Microscope and Software must be confirmed by trained personnel.

    Assay: The EUROIMMUN IFA 40: HEp-20-10 EUROPattern is an indirect immunofluorescence antibody test for the qualitative or semiquantitative determination of IgG antibodies against antibody (ANA) in human serum with the EUROPattern Microscope and Software automated instrument. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

    Device Description

    The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides.

    AI/ML Overview

    The provided text is a cover letter from the FDA to EUROIMMUN US INC. regarding the 510(k) premarket notification for their EUROIMMUN IFA 40: HEp-20-10 EUROPattern and EUROPattern Microscope and Software. While it states that FDA has determined the device is substantially equivalent to a predicate device, and outlines the indications for use, it does not contain any information about acceptance criteria, device performance results, specific study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table and study details based on the provided document. The document focuses on regulatory approval and compliance rather than technical performance data.

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