BAYER IMMUNO 1 COMPLEXED PSA ASSAY
FDA premarket approval P990055 · decided 2000-09-08
Approval details
- PMA number
- P990055
- Trade name
- BAYER IMMUNO 1 COMPLEXED PSA ASSAY
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 1999-10-01
- Decision date
- 2000-09-08
- Days to decision
- 343 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE BAYER IMMUNO 1(TM) COMPLEXED PSA ASSAY. THE IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM ON THE BAYER IMMUNO 1(TM) SYSTEM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. BIOPSY OF THE PROSTATE IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS DEVICE IS FURTHER INDICA
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