Atellica IM free PSA II (fPSAII)
by Siemens Healthcare Diagnostics
PMA P250026
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP250026 | Date11 May 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- FDA applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA Number
- FDA Product Code
- MTG
- Device Class
- Class III
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Atellica IM free PSA II (fPSAII) assay is an in vitro diagnostic test for the quantitative measurement of free prostate-specific antigen (fPSA) in human serum and plasma. It is designed to be used alongside the Atellica IM total PSA II (tPSAII) assay in men aged 50 years and older with total PSA values between 4 ng/mL and 10 ng/mL and a non-suspicious digital rectal examination. The percent free PSA value derived from this test assists in distinguishing prostate cancer from benign prostatic conditions, though a prostate biopsy remains necessary for definitive diagnosis.
The assay is supplied for use on the Atellica IM Analyzer and is intended for single-use applications. It is not indicated for use in other patient populations or for other diagnostic purposes. The device is regulated under FDA premarket approval (PMA) and is classified as a Class III medical device. Proper storage and handling procedures must be followed to ensure accuracy and reliability of results.
Other devices from Siemens Healthcare Diagnostics
Questions
AI-generated answers, 18 Sep 2026
What specific patient population is the Atellica IM free PSA II (fPSAII) intended for, and how does it work alongside other tests?
The Atellica IM free PSA II (fPSAII) is designed for men aged 50 years and older who have total PSA values between 4 ng/mL and 10 ng/mL, along with a non-suspicious digital rectal examination (DRE). It measures free prostate-specific antigen (fPSA) in human serum or plasma (using lithium heparin or EDTA) to calculate the percent free PSA. This value, derived alongside the Atellica IM total PSA II (tPSAII) assay, helps distinguish prostate cancer from benign prostatic conditions. However, a prostate biopsy is still required for a definitive diagnosis.
Is the Atellica IM free PSA II (fPSAII) assay reusable, and what type of analyzer does it require?
The Atellica IM free PSA II (fPSAII) is intended for single-use applications only. It is specifically designed to be used exclusively on the Atellica IM Analyzer, which is the only platform authorized for this assay.
What types of sample matrices are compatible with the Atellica IM free PSA II (fPSAII) assay?
The assay is compatible with human serum and plasma samples collected using lithium heparin or EDTA as anticoagulants. It is not intended for use with other sample types or patient populations.
How is the Atellica IM free PSA II (fPSAII) regulated, and what class does it fall under?
The Atellica IM free PSA II (fPSAII) is regulated under the FDA’s premarket approval (PMA) process and is classified as a Class III medical device. This classification reflects its role in aiding critical diagnostic decisions for prostate cancer risk assessment.
What storage and handling procedures should be followed to ensure accurate results with the Atellica IM free PSA II (fPSAII)?
While specific storage details are not provided in the data, the assay requires proper storage and handling procedures to maintain accuracy and reliability. Since it is single-use and designed for the Atellica IM Analyzer, adherence to manufacturer guidelines (likely included in the device’s instructions) is essential to prevent contamination or degradation of the test components.