Atellica IM Anti-HBe2 (aHBe2)
FDA premarket approval P200017/S003 · decided 2025-03-20
Approval details
- PMA number
- P200017
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Anti-HBe2 (aHBe2)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2024-09-26
- Decision date
- 2025-03-20
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- approval for the Migration of the Siemens ADVIA Centaur aHBe2 assay (P200017) from the ADVIA Centaur XP to Atellica CI system (referred to as Atellica CI analyzer), which will be known as Atellica IM aHBe2 assay
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica CH Acetaminophen 2 (ACTM) (K261364) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 |
| Atellica CH Diazo Total Bilirubin (D_TBil) (K251998) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 |
| Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 |
| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
| ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| ADVIA Centaur Anti-Thyroid Peroxidase II (K250250) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Thyroglobulin (Tg) (K242981) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| Atellica® CH Creatinine_3 (Crea3) (K242685) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 |