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® Anti-HBs ReadyPack Reagents
ADVIA Centaur® Anti-HBs ReadyPack Calibrators
Applicant: Bayer HealthCare LLC
Address: 511 Benedict Avenue, Tarrytown, NY 10591-5097
Approval Date: September 10, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030029a.pdf
What is it? The Anti-HBs ReadyPack Reagents and Calibrators are part of a lab test that detects antibodies to the hepatitis B virus surface antigen (anti-HBs). Antibodies are substances produced by the body to fight against foreign substances called antigens, such as the hepatitis B virus (HBV). The purpose of this test is to determine if the patient has been previously infected with HBV or is immune to HBV infection. This test is performed after vaccination against HBV or following an active infection. This test can only be run on the Bayer ADVIA Centaur® System.
How does it work?
- Patient blood serum being tested for anti-HBs is placed into tubes with the ReadyPack Reagents that contain hepatitis B virus antigen coupled to magnetic latex particles.
- If there are anti-HBs 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 anti-HBs in the patient’s blood serum.
Calibrators help ensure that the test gives the correct results. They help assure that the test system shows the status of a patient’s immunity to HBV consistent with current Centers for Disease Control and Prevention’s recommendation.
When is it used? The Anti-HBs ReadyPack is used to determine whether a patient has had a previous infection by HBV or to determine if a patient needs to be vaccinated with HBV vaccine.
What will it accomplish? Test results help determine whether a patient should be advised to receive the hepatitis B virus vaccine.
When should it not be used? The Anti-HBs ReadyPack 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=p030029