PMA P950021S004
- Device
- TOTAL PSA MICROTITER ELISA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S004
- Product code
- LTJ
- Decision date
- 2002-03-19
- 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 TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING: THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE TOTAL PSA IN HUMAN SERUM. THE ASSAY DETECTS PSA BOTH AS A FREE MOLECULE, AND WHEN COMPLEXED BY OTHER MOLECULES, PRINCIPALLY ALPHA-1-ANTICHYMOTRYPSIN (ACT). THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS FURTHER INDICATED FOR FOLLOW-UP AND MONITORING OF PATIENTS WITH PROSTATE CANCER. PSA LEVELS MEASURED BY THIS DEVICE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL AND OTHER DIAGNOSTIC PROCEDURES IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
Current openFDA PMA Record#
- Device
- TOTAL PSA MICROTITER ELISA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S004
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2002-03-19
- Decision code
- APPR
- Date received
- 2001-09-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING: THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE TOTAL PSA IN HUMAN SERUM. THE ASSAY DETECTS PSA BOTH AS A FREE MOLECULE, AND WHEN COMPLEXED BY OTHER MOLECULES, PRINCIPALLY ALPHA-1-ANTICHYMOTRYPSIN (ACT). THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS FURTHER INDICATED FOR FOLLOW-UP AND MONITORING OF PATIENTS WITH PROSTATE CANCER. PSA LEVELS MEASURED BY THIS DEVICE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL AND OTHER DIAGNOSTIC PROCEDURES IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.