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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval
Product Name: Bayer ADVIA Centaur® HAV IgM Assay
Applicant: Bayer HealthCare LLC
Address: 511 Benedict Avenue, Tarrytown, NY 10591-5097
Approval Date: December 22, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040018a.pdf
What is it? The Bayer ADVIA Centaur® HAV IgM Assay is a lab test used with the Bayer ADVIA Centaur® System to detect antibodies associated with hepatitis A infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as the hepatitis A virus (HAV). IgM antibody to hepatitis A antigen (anti-HAV IgM) is an early antibody that normally appears during an HAV infection. The purpose of this test is to determine if the patient is currently or has recently been infected with HAV.
How does it work?
- A patient’s blood serum being tested for IgM antibodies to HAV is placed into tubes with the ReadyPack Reagents which contain anti-human IgM coupled to magnetic latex particles.
- If there are HAV specific IgM antibodies in the blood, antibody-antigen complexes will form.
- These antibody-antigen complexes react with another reagent in the ReadyPack to produce light.
- The amount of light produced is measured and a determination is made whether there is IgM antibodies to HAV in the patient’s blood serum.
When is it used? This test is used to determine if a patient is infected with the hepatitis A virus.
What will it accomplish? This test will determine whether a patient has a current or recent infection by hepatitis A virus. Test results may also be used to help rule out other types of viral hepatitis such as hepatitis B and hepatitic C viruses.
When should it not be used? This test should not be used if it is not ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood donors.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040018