Atellica IM Total PSA II (tPSAII)
FDA premarket approval P240021 · decided 2025-12-03
Approval details
- PMA number
- P240021
- Trade name
- Atellica IM Total PSA II (tPSAII)
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2024-06-20
- Decision date
- 2025-12-03
- Days to decision
- 531 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the Atellica IM total PSA II (tPSAII):The Atellica IM total PSA II (tPSAII) assay is for in vitro diagnostic use in the quantitative measurement of total prostate-specific antigen (PSA) in human serum and plasma (EDTA and lithium-heparin) using the Atellica IM Analyzer. This assay is indicated as an aid in the detection of prostate cancer in conjunction with a digital rectal exam (DRE) in men aged 50 years and older. A prostate biopsy is required for the diagnosis of prostate cancer
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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 |