ADVIA Centaur and Atellica IM HBsAgII

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Advia Centaur Hbsagii

Generic Name

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

PMA Number

P110041 ↗

FDA Product Code

LOM

Device Class

Class II

Regulation

21 CFR Part 866.3172

Advisory Committee

Microbiology

FDA Decision

APRL

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• What types of samples can the ADVIA Centaur HBsAgII assay detect Hepatitis B surface antigen in, and what collection tubes are compatible?

  The ADVIA Centaur HBsAgII assay is designed to detect Hepatitis B surface antigen (HBsAg) in human serum and plasma samples from adults, adolescents, pediatric patients, and neonates. Compatible collection tubes include those containing EDTA-A, lithium-heparin, or sodium-heparin. This broad compatibility ensures flexibility for different clinical settings and patient populations.

• How is the ADVIA Centaur HBsAg Confirmatory assay used in the diagnostic workflow, and what sample types does it support?

  The ADVIA Centaur HBsAg Confirmatory assay is used to validate repeatedly reactive results from the initial ADVIA Centaur HBsAgII assay. It supports human serum and plasma samples collected in potassium EDTA, lithium-heparin, or sodium-heparin tubes, as well as neonatal samples. This step helps confirm the presence of HBsAg in cases where the initial test was positive, reducing false positives.

• Are the reagents for the ADVIA Centaur HBsAgII system single-use, and if so, what does this mean for workflow and inventory management?

  Yes, all components of the ADVIA Centaur HBsAgII system—including the HBsAgII assay, HBsAg Confirmatory assay, and Quality Control Material—are supplied as single-use reagents. This design ensures patient safety by preventing cross-contamination and simplifies workflow by eliminating the need for cleaning or reprocessing between uses. Clinicians must order and stock these reagents accordingly, accounting for their one-time use per test.

• What is the purpose of the ADVIA Centaur HBsAg Quality Control Material, and on which systems is it intended to be used?

  The ADVIA Centaur HBsAg Quality Control Material is specifically designed to monitor the performance of the HBsAgII and HBsAg Confirmatory assays exclusively on the ADVIA Centaur systems. It helps laboratories verify the accuracy and reliability of their testing processes, ensuring consistent results for patient diagnosis. It is not compatible with other systems or assays, so its use is limited to ADVIA Centaur platforms.

• What regulatory pathway was followed for the approval of these assays, and what device classification does it fall under?

  The ADVIA Centaur HBsAgII, HBsAg Confirmatory, and Quality Control Material were approved through the FDA’s Premarket Approval (PMA) process under PMA number P110041. These assays are classified under device code LOM and fall under Class II medical devices, as indicated by the OpenFDA data. This classification reflects their role in diagnosing Hepatitis B infection, which requires rigorous validation before market authorization.