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510(k) Data Aggregation

    K Number
    K040160
    Device Name
    QUANTA PLEX SLE PROFILE 8
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2004-03-08

    (45 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 QUANTA Plex™ SLE Profile 8 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, SCL-70, Jo-1, Ribosomal P and Centromere B autoantibodies in human serum. The presence of these autoantibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as mixed connective tissue disease, Sjogren's syndrome, scleroderma and polymyositis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

    The document is primarily the FDA's formal response to a premarket notification for the "QUANTA Plex™ SLE Profile 8" device, confirming its substantial equivalence to legally marketed predicate devices. It briefly states the indications for use on page 6 (document page 3).

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