PMA P950021S006
- Device
- BAYER ADVIA IMS PSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S006
- Product code
- MTF
- Decision date
- 2003-09-02
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- APPROVAL OF THE IMMUNO 1 PROSTATE SPECIFIC ANTIGEN (PSA) ON THE ADVIA INTEGRATED MODULAR SYSTEM (IMS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) AND IS INDICATED FOR: THE ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) METHOD IS FOR IN VITRO DIAGNOSTIC USE TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF THE SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEAR AND OLDER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS. THIS DIAGNOSTIC METHOD IS NOT INTENDED FOR USE ON ANY OTHER SYSTEM.
Current openFDA PMA Record#
- Device
- BAYER ADVIA IMS PSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S006
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2003-09-02
- Decision code
- APPR
- Date received
- 2003-07-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF THE IMMUNO 1 PROSTATE SPECIFIC ANTIGEN (PSA) ON THE ADVIA INTEGRATED MODULAR SYSTEM (IMS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) AND IS INDICATED FOR: THE ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) METHOD IS FOR IN VITRO DIAGNOSTIC USE TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF THE SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEAR AND OLDER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS. THIS DIAGNOSTIC METHOD IS NOT INTENDED FOR USE ON ANY OTHER SYSTEM.