PMA P910065S001
- Device
- ST AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S001
- Product code
- LTJ
- Decision date
- 1999-09-10
- 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 for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P910065S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ST AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S001
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 1999-09-10
- Decision code
- APPR
- Date received
- 1999-03-25
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System 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.