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    K Number
    K984153
    Device Name
    THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-01-11

    (53 days)

    Product Code
    LJZ,83L
    Regulation Number
    866.3375
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.

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

    Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the manual or automated, qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.

    Device Description

    Aptus (automated) Application for the Mycoplasma IgM ELISA Test System

    AI/ML Overview

    This is a letter from the FDA to Zeus Scientific, Inc. regarding the 510(k) premarket notification for their Aptus (automated) Application of the Mycoplasma IgM ELISA Test System. This document DOES NOT contain the acceptance criteria or details of a study proving the device meets acceptance criteria. It primarily addresses the substantial equivalence determination and regulatory requirements for marketing the device.

    Therefore, I cannot provide the requested information based on the provided text.

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