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U.S. Department of Health and Human Services

Medical Devices

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ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems - P100039

Photo of ADVIA® Centaur Anti-HBs2 HBV Test

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 Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA Centaur and ADVIA Centaur XP Systems
PMA Applicant: Siemens Healthcare Diagnostics
Address:
511 Benedict Avenue, Tarrytown, NY 10591
Approval Date:
January 20, 2012
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100039a.pdf

What is it? ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of these specific antibodies against the hepatitis B surface antigen can help determine if a person is susceptible to HBV infection or has previously been infected with HBV. The test may also be used to help determine if a person is susceptible to HBV infection before or following an HBV vaccination. This test is designed for use on the ADVIA Centaur and ADVIA Centaur XP systems, which runs the test and analyzes the results.

How does it work? A person’s blood sample is added to a tube (vial) with the test chemicals. If there are antibodies to the hepatitis B surface antigen in the blood, they attach to special microparticles which cause them to emit light. The light signal is measured by the ADVIA Centaur or ADVIA Centaur XP systems. The Anti-HBs2 (aHBs2) controls are used as a quality control to ensure that the test is working properly.

When is it used? The test result is used in combination with other clinical information and blood tests to aid in the diagnosis of individuals with signs and symptoms of hepatitis, or in individuals at risk for hepatitis B infection.

What will it accomplish? Results of this lab test, in combination with other clinical information and laboratory blood tests, may be used by the clinician to aid in the diagnosis of patients with the symptoms of hepatitis or who may be at risk for HBV infection.

When should it not be used? This test should not be used to monitor HBV disease or therapy.

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

Other Resources: