ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay
FDA premarket approval P110041/S015 · decided 2025-03-04
Approval details
- PMA number
- P110041
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Corp.
- Date received
- 2024-09-13
- Decision date
- 2025-03-04
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for migration of the ADVIA Centaur HBsAg II (HBsII) and the ADVIA Centaur HBsAg Confirmatory (Conf) Assay, and the HBsAg II Quality Control (HBsII QC) onto the Atellica CI analyzer, which will be known as the Atellica IM HBsAg II (HBsII) and Atellica IM HBsAg II Confirmatory (HBsII Conf) Assay.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (K103360) | Siemens Corp. | 2010-12-17 |
| KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY (K993947) | Siemens Corp. | 1999-12-21 |
| AX WORKSTATION DR-VIEWER SOFTWARE OPTION (K992925) | Siemens Corp. | 1999-11-23 |
| HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM (K991652) | Siemens Corp. | 1999-08-03 |
| SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION (K991600) | Siemens Corp. | 1999-06-09 |
| FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR (K984221) | Siemens Corp. | 1999-02-12 |
| PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS (K984224) | Siemens Corp. | 1999-02-02 |
| PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE (K982536) | Siemens Corp. | 1998-11-24 |