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: 
ADVIA Centaur® HBsAgII for use on the ADVIA Centaur® and ADVIA Centaur® XP 
ADVIA Centaur® HBsAg Confirmatory
ADVIA Centaur® HBsAg Quality Control Material

PMA Applicant: Siemens Healthcare Diagnostics 
Address: 511 Benedict Ave., Tarrytown, NY 10591
Approval Date: May 16, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110041a.pdf

What is it? This product is used with the ADVIA Centaur or ADVIA Centaur XP Instrument Systems to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.

How does it work?

  • A sample of the patient's blood is placed into reaction wells containing microparticles coated with antibodies to HBV.
  • If the blood sample contains HBV proteins, they will bind to the microparticles in the reaction wells.
  • This reaction is detected by another substance that produces light, which is then measured to determine the presence of HBV in the blood.
  • If this first test is positive, the patient's blood is retested to confirm the presence of HBV with the ADVIA Centaur HBsAg Confirmatory assay.

When is it used? This test is used to provide evidence of whether or not a person is infected with HBV.

What will it accomplish? It can be used for testing pediatrics and adults including pregnant women to see if a person has evidence of HBV infection or if a neonate may be at high risk for HBV infection.

When should it not be used? This assay has not been FDA-cleared or approved for the screening of blood or plasma donors.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.