This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: AxSYM CORE-M ™ 2.0 AxSYM CORE-M ™ 2.0 Controls
PMA Applicant: Abbott Laboratories
Address: Abbott Laboratories, Diagnostics Division, 100 Abbott Park Road, Abbott Park. IL 60064-6092
Approval Date: August 25, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060009a.pdf
What is it? This device is a laboratory test that detects antibody associated with acute or recent infection with hepatitis B virus (HBV) (IgM antibody to hepatitis B virus core antigen, IgM anti-HBc). Antibodies are substances produced by the body to fight against foreign organisms called antigens, such as HBV. This test helps in the diagnosis of acute or recent hepatitis B virus infection, together with other laboratory results and clinical information.
This test is used with Abbott AxSYM ® Instrument System.
How does it work?
- The patient’s blood serum/plasma sample and anti-human IgM coated microparticles are combined.
- If there is IgM anti-HBc antibody in the sample, antibody-antigen complexes will form.
- These antibody-antigen complexes further react with recombinant hepatitis B virus core antigen and another substance that produces light.
- The amount of light is measured to determine the presence of IgM anti-HBc in the patient’s blood.
When is it used and what will it accomplish? This lab test is used, together with other laboratory results and clinical information, to help determine whether a patient has an acute or recent HBV infection. Depending on the stage of infection, doctors may recommend appropriate treatment.
When should it not be used? This test should not be used if it is not ordered by a physician. This test should not be used for screening blood donors. Performance of the test has not been established for patients who are immunocompromised or immunosuppressed.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060009