LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250666

    Validate with FDA (Live)

    Device Name
    Alegria Flash CTD Screen
    Manufacturer
    ZEUS Scientific
    Date Cleared
    2025-10-22

    (231 days)

    Product Code
    LLL
    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 Alegria Flash CTD Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to SSA-60, SSA-52, SS-B, Jo-1, Scl-70, SmRNP, Sm, dsDNA, Ribosomal P, Nucleosome, and Centromere-B in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD): Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Limited Cutaneous Systemic Sclerosis (CREST Syndrome), polymyositis, and dermatomyositis along with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.

    Device Description

    Not Found

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1