BAYER ADVIA IMS COMPLEXED PSA ASSAY
FDA premarket approval P990055/S008 · decided 2005-10-07
Approval details
- PMA number
- P990055
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAYER ADVIA IMS COMPLEXED PSA ASSAY
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2005-07-22
- Decision date
- 2005-10-07
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL OF THE ACS:180 AND THE CENTAUR COMPLEXED PSA (CPSA) ASSAYS ON THE ADVIA CENTAUR CP SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP CPSA AND IS INDICATED: THE IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE ADVIA CENTAUR SYSTEM. THE ASSAY IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION
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