LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994379
    Device Name
    EU-TTG IGA ELISA
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2000-02-18

    (53 days)

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

    EU-TTG IGA ELISA

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

    Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.

    Device Description

    Enzyme Immunoassay Kit

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Eu-tTG® IgA Assay." This document is a regulatory communication, not a study report or clinical trial summary.

    Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets and ground truth establishment.

    The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use as "an aid in the diagnosis of Celiac Disease."

    To obtain the requested information, one would need to consult the actual 510(k) submission document (K994379) itself, which would include the study data and performance claims.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1