PMA P910065S005
- Device
- ST AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S005
- Product code
- LTJ
- Decision date
- 2004-05-25
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- APPROVAL OF THE TOSOH ST AIA-PACK PA ASSAY TO BE USED ON THE TOSOH AIA-360 AND TOSOH AIA-1800 AUTOMATED IMMUNOASSAY SYSTEMS, MEMBERS OF THE TOSOH AIA AUTOMATED IMMUNOASSAY SYSTEM FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME 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, AIA-600 II, AIA-1800 AND AIA-360 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. THIS 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.
Current openFDA PMA Record#
- Device
- ST AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S005
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2004-05-25
- Decision code
- APPR
- Date received
- 2004-04-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL OF THE TOSOH ST AIA-PACK PA ASSAY TO BE USED ON THE TOSOH AIA-360 AND TOSOH AIA-1800 AUTOMATED IMMUNOASSAY SYSTEMS, MEMBERS OF THE TOSOH AIA AUTOMATED IMMUNOASSAY SYSTEM FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME 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, AIA-600 II, AIA-1800 AND AIA-360 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. THIS 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.