LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081615
    Device Name
    OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    2009-03-18

    (282 days)

    Product Code
    DHX,JIT,JJX
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

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

    The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only.

    The Olympus CEA Calibrator is for calibrating the quantitative Olympus CEA assay on the Olympus AU3000i Immunoassay System.

    The Olympus CEA Control is used for quality control of the Olympus CEA assay on the Olympus AU3000i Immunoassay System.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically regarding device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is primarily an FDA 510(k) clearance letter and an "Indications for Use" statement for the Olympus Carcinoembryonic antigen (CEA) Test System. It confirms the device's substantial equivalence to a predicate device and outlines its intended use but does not delve into the specifics of performance studies or acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1