PMA P250026
- Device
- Atellica IM free PSA II (fPSAII)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P250026
- Product code
- MTG
- Decision date
- 2026-05-11
- Classification
- Immunology
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order 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) and 10 ng/mL (µg/L) and a digital rectal examination (DRE) non-suspicious for cancer to determine the percent free PSA value. The percent free PSA value can be used as an aid in discriminating between prostate cancer and benign prostatic disease. A prostate biopsy is required for the diagnosis of prostate cancer.
Current openFDA PMA Record#
- Device
- Atellica IM free PSA II (fPSAII)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P250026
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2026-05-11
- Decision code
- APPR
- Date received
- 2025-07-18
- Approval order 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) and 10 ng/mL (µg/L) and a digital rectal examination (DRE) non-suspicious for cancer to determine the percent free PSA value. The percent free PSA value can be used as an aid in discriminating between prostate cancer and benign prostatic disease. A prostate biopsy is required for the diagnosis of prostate cancer.