Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
• Generic Name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
• Regulation Number: 866.3172
• Applicant: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave.; New York, NY 10591
• PMA Number: P210019
• Supplement Number: S002
• Date Received: 10/31/2022
• Decision Date: 04/28/2023
• Reclassified Date: 10/20/2025
• Product Code: LOM
• Docket Number: 23M-1698
• Notice Date: 05/01/2023
• Advisory Committee: Microbiology
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approve inclusion of pediatric subjects in the intended use population for the ADVIA Centaur XP/XPT, ADVIA Centaur CP, and Atellica IM Analyzers

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling