Atellica IM free PSA II (fPSAII)
FDA premarket approval P250026 · decided 2026-05-11
Approval details
- PMA number
- P250026
- Trade name
- Atellica IM free PSA II (fPSAII)
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2025-07-18
- Decision date
- 2026-05-11
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the Atellica IM free PSA II (fPSAII):The Atellica IM free PSA II (fPSAII) assay is for in vitro diagnostic use in the quantitative measurement of free prostate-specific antigen (fPSA) in human serum and plasma (lithium heparin and EDTA) using the Atellica IM Analyzer. The Atellica IM fPSAII assay is intended to be used in conjunction with the Atellica IM total PSA II (tPSAII) assay in men aged 50 years and older with total prostate-specific antigen (PSA) values between 4 ng/mL (µg/L
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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 |