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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAtellica IM Total PSA II (tPSAII)
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP240021
Supplement NumberS001
Date Received02/27/2026
Decision Date08/26/2026
Product Code MTF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 CI 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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