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: ADVIA Centaur® HBc Total ReadyPack Reagents
ADVIA Centaur® HBc Total Quality Control Materials
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/p040004a.pdf
What is it? The ADVIA Centaur® HBc Total Assay is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as the hepatitis B virus (HBV). The presence of HBV antibodies can help determine if the patient is currently or has previously been infected with HBV.
How does it work?
- Patient blood serum being tested for hepatitis B core antigen total antibodies (anti-HBc) is placed into tubes with the ReadyPack Reagents which contain hepatitis B core antigen coupled to magnetic latex particles.
- If there are antibodies to hepatitis B core antigen (anti-HBc) present 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 gives the amount of anti-HBc that were in the patient’s blood serum.
- The quality control materials help to monitor the performance of the anti-HBc Total assay.
When is it used? This test is used to determine if the patient has been infected with the HBV.
What will it accomplish? Test results help determine the clinical stage of HBV infection in the patient and what treatment may be needed.
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=p040004