Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Basic Information
- Device Name
- Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- Trade Name
- BAYER ADVIA IMS PSA ASSAY
- PMA Number
- P950021
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MTF
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 2, 2003
- Date Received
- July 16, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
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 |
|---|---|---|---|
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | FDA class 3 | Unknown |