BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS
FDA premarket approval P990055/S001 · decided 2001-12-07
Approval details
- PMA number
- P990055
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2001-03-27
- Decision date
- 2001-12-07
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADDITION OF THE ASSAY TO THE BAYER ACS:180 AND ADVIA CENTAUR ANALYZERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BAYER ACS:180 OR ADVIA CENTAUR COMPLEXED PSA ASSAY AND ARE INDICATED AS FOLLOWS: THIS IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE BAYER DIAGNOSTICS IMMUNO 1, THE ACS:180 SYSTEM, OR THE ADVIA CENTAUR SYSTEM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXE
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