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 HBc Total 2 (HBcT2)
ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC)
Atellica IM HBc Total 2 (HBcT2)
Atellica IM HBc Total 2 Quality Control (HBcT2 QC)
PMA Applicant: Siemens Healthcare Diagnostics Inc.
Address: 511 Benedict Ave. Tarrytown, NY 10591
Approval Date: July 27, 2022
Approval Letter: Approval order
What is it?
The ADVIA Centaur Anti-HBc2 and Atellica IM HBc Total 2 (HBcT2) assays are laboratory tests used to detect antibodies to a protein on the surface of the hepatitis B virus, the c antigen (HBc). The ADVIA Centaur Anti-HBc2 and Atellica IM HBc Total 2 (HBcT2) assay is used with the laboratory systems ADVIA Centaur XP and ADVIA Centaur XPT.
How does it work?
A sample of the patient’s blood is sent to a clinical laboratory. At the laboratory, the blood sample is processed to separate the plasma. The sample is then mixed with test chemicals and system then measures and reports if antibodies to HBc are detected. A laboratory clinician reviews the results and sends a report to the healthcare provider.
When is it used?
Results from this test are used together with clinical information and other laboratory results to help health care providers diagnose people with hepatitis B. This test is indicated for use in people with signs or symptoms, risk factors, or known hepatitis B infection.
What will it accomplish?
Detecting antibodies to HBc, when combined with other clinical information and test results, helps healthcare providers to determine whether someone is infected with hepatitis B.
When should it not be used?
There are no known reasons not to use this test.