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510(k) Data Aggregation

    K Number
    K231616
    Device Name
    ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
    Manufacturer
    ZEUS Scientific
    Date Cleared
    2023-08-31

    (90 days)

    Product Code
    KTL,PIV
    Regulation Number
    866.5100
    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 IFA™ nDNA Test System is an indirect immunofluorescence assay utilizing Crithidia luciliae for the qualitative and semi-quantitative determination of anti-native DNA (nDNA) IgG antibodies to DNA in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of nDNA antibodies in conjunction with other serological and clinical findings can be used to aid in the diagnosis of systemic lupus erythematosus (SLE).

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA clearance letter for the ZEUS IFA nDNA Test System. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a standard FDA 510(k) clearance letter, confirming the device's substantial equivalence to a predicate device and outlining regulatory obligations.

    Therefore, I cannot provide the requested information based on the provided input. The details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory document.

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