Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Basic Information
- Device Name
- Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Trade Name
- Atellica IM free PSA II (fPSAII)
- PMA Number
- P250026
- Device Class
- FDA Class 3
- Product Code
- MTG
- Generic Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 11, 2026
- Date Received
- July 18, 2025
- Expedited Review
- N
- Docket Number
- 26M-5545
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | FDA class 3 | Unknown |