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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceAtellica IM free PSA II (fPSAII)
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP250026
Date Received07/18/2025
Decision Date05/11/2026
Product Code MTG 
Docket Number 26M-5545
Notice Date 05/11/2026
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
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