PMA P240021S001

Device: Atellica IM Total PSA II (tPSAII)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P240021
Supplement: S001
Product code: MTF
Decision date: 2026-08-26
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 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.

Current openFDA PMA Record#

Device: Atellica IM Total PSA II (tPSAII)
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P240021
Supplement: S001
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2026-08-26
Decision code: APPR
Date received: 2026-02-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.