LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023597
    Device Name
    ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2002-12-11

    (44 days)

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

    ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY

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

    The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

    Device Description

    The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Access® OV Monitor ELISA

    This document outlines the acceptance criteria and the performance of the Access® OV Monitor assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Analytical Performance
    Specificity (Therapeutic Drugs)No significant interference (
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1