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510(k) Data Aggregation

    K Number
    K983921
    Device Name
    AUTOSTAT II ENA SCREEN ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1998-12-28

    (54 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 results of the ENA screen assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), Poly/Dermato Myositis (PM/DM), Scleroderma and CREST. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Autostat™II ENA-6 Screen Kit." It primarily discusses the regulatory approval and substantial equivalence to a predicate device. This document does not contain specific acceptance criteria or details of a study demonstrating the device's performance against such criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than the technical performance study details.

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