PMA P240021
- Device
- Atellica IM Total PSA II (tPSAII)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P240021
- Product code
- MTF
- Decision date
- 2025-12-03
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order 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.
Current openFDA PMA Record#
- Device
- Atellica IM Total PSA II (tPSAII)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P240021
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2025-12-03
- Decision code
- APPR
- Date received
- 2024-06-20
- Approval order 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.