Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Basic Information
- Device Name
- Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Trade Name
- ST AIA-PACK PA
- PMA Number
- P910065
- Supplement Number
- S004
- Device Class
- FDA Class 2
- Product Code
- LTJ
- Generic Name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 12, 2003
- Date Received
- June 4, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR DESIGN CHANGES TO INCLUDE REDUCTION OF THE INCUBATION TIME FROM 40 TO 10 MINUTES, CHANGE IN THE CONJUGATE DILUENT, DECREASE IN ALP ACTIVITY AND CHANGE IN PACKAGING SIZE FROM 200 TESTS TO 100 TESTS PER BOX. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST AIA-PACK PA AND IS INDICATED FOR: ST AIA-PACK PA IS DESIGNED FOR IN VITRO DIAGNOSTIC USE ONLY FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM ON TOSOH AIA NEX*IA AND TOSOH AIA-600 II ANALYZERS. THIS 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 (CAP) IN MEN FIFTY YEARS OF AGE AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER. THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA IN HUMAN SERUM TO BE USED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATIC 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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |