ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY
FDA premarket approval P950021/S002 · decided 2000-12-22
Approval details
- PMA number
- P950021
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2000-07-31
- Decision date
- 2000-12-22
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ACS:180 AND ADVIA CENTAUR IMMUNOASSAY ANALYZERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS:180 PSA IMMUNOASSAY AND ADVIA CENTAUR PSA IMMUNOASSAY AND IS INDICATED FOR THE FOLLOWING: THE BAYER ACS:180(TM) AND ADVIA CENTAUR(TM) PSA ASSAYS ARE IN VITRO DEVICES INTENDED FORO THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THESE DEVICES ARE INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE)
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