LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993213
    Device Name
    K-ASSAY IGA
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-23

    (60 days)

    Product Code
    CFF
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY IGA

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

    The K-ASSAY IgA Assay is intended to be used for the quantitative determination of IgA in human serum by immunoturbidimetric assay. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "K-ASSAY IgA". It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for.

    The letter focuses on regulatory approval and mentions the intended use of the device: "The K-ASSAY IgA Assay is intended to be used for the quantitative determination of IgA in human serum by immunoturbidimetric assay. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE."

    Therefore, I cannot provide the specific information requested about acceptance criteria and study details from the provided text. To obtain that information, you would typically need to refer to the original 510(k) submission summary or detailed study reports, which are not included in this FDA clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1