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510(k) Data Aggregation

    K Number
    K020583
    Device Name
    IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
    Manufacturer
    IVD RESEARCH, INC.
    Date Cleared
    2002-09-17

    (208 days)

    Product Code
    MHI
    Regulation Number
    866.3220
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

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

    This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces.

    Device Description

    It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Giardia Antigen Detection Microwell ELISA Assay. It does not contain information about acceptance criteria, device performance, sample sizes for testing/training, ground truth establishment, or human reader effectiveness studies.

    The provided text is purely an FDA clearance letter and an "Indication For Use" statement. It does not include a study description with the requested details. Therefore, I cannot extract the information to complete the table or answer the questions.

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