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
- ACCESS HYBRITECH PSA WHO STANDARDIZATION
- PMA Number
- P850048
- Supplement Number
- S021
- 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
- May 9, 2008
- Date Received
- August 21, 2007
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 08M-0425
Advisory Committee Statement
APPROVAL FOR THE ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS. THE ACCESS HYBRITECH PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. THE DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER. THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA TO AID IN THE PROGNOSIS AND MANAGEMENT OF PATIENTS WITH 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 |
|---|---|---|---|
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | FDA class 3 | Unknown |