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510(k) Data Aggregation

    K Number
    K965094
    Device Name
    HYCOR ALLERGEN DISC
    Manufacturer
    HYCOR BIOMEDICAL, INC.
    Date Cleared
    1997-05-21

    (153 days)

    Product Code
    DHB
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYCOR ALLERGEN DISC

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

    These assays (RIA&EIA) are to be used to detect antibodies (IgE) in a single serum specimen. The results of the latex assay can be used as an aid in diagnosis of allergy to latex.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a medical device called "HYCOR Allergen Disc (K82)", which is used to detect IgE antibodies to Hevea braziliensis (Latex) as an aid in diagnosing latex allergy.

    However, the provided document is a clearance letter from the FDA and does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your bullet points (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

    This document simply states that the FDA has reviewed the 510(k) and found the device to be substantially equivalent to legally marketed predicate devices, thus allowing it to be marketed. The technical performance data, including acceptance criteria and study details, would have been part of the original 510(k) submission, which is not provided here.

    Therefore, I cannot extract the requested information from the given text.

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