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510(k) Data Aggregation

    K Number
    K991890
    Device Name
    AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-08-09

    (67 days)

    Product Code
    MVJ
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

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

    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane(GBM) in human serum. The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. For in vitro diagnostic use only.

    Device Description

    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GBM in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for two devices: Autostat™ Anti-GBM ELISA and HY•TEC Anti-GMB ELISA. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices.

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