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510(k) Data Aggregation

    K Number
    K994338
    Device Name
    AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-02-03

    (42 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

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

    ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA. USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS . LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) clearance letter for the "Autostat™ II Rheumatoid Factor IgM ELISA" device, indicating that it has been deemed substantially equivalent to a legally marketed predicate device.

    The letter does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about the sample size, data provenance, number of experts, adjudication methods for ground truth, or qualifications of experts.
    • Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Details about standalone algorithm performance studies.
    • The type of ground truth used for any studies.
    • Information about the training set size or how its ground truth was established.

    The document only states the device's trade name, regulatory class, product code, and its intended use: "ENZYME LINKED IMMUNOSORBENT ASSAY METHOD FOR THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGM RHEUMATOID FACTOR (RF) ANTIBODIES IN HUMAN SERA. USES: THE RESULTS OF THE RF IGM ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF RHEUMATOID ARTHRITIS (RA) WHEN SUPPORTED BY OTHER LABORATORY AND CLINICAL INVESTIGATIONS. LEVELS OF THESE AUTOANTIBODIES ARE ONE INDICATION IN A MULTIFACTORIAL DIAGNOSTIC SCHEME. THE ASSAY MAY BE USED ON THE HAAKE HYPOTEC AUTOMATED EIA INSTRUMENT. FOR IN VITRO DIAGNOSTIC USE ONLY."

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