ADVIA CENTAUR CP PSA ASSAY
FDA premarket approval P950021/S007 · decided 2005-10-07
Approval details
- PMA number
- P950021
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR CP PSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2005-07-22
- Decision date
- 2005-10-07
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR TRANSFER OF THE ASSAY TO A NEW BAYER PLATFORM, THE ADVIA CENTAUR CP SYSTEM. THE ADVIA CENTAUR CP PSA ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC-ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR CP SYSTEM.
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