BAYER ADVIA IMS PSA ASSAY
FDA premarket approval P950021/S006 · decided 2003-09-02
Approval details
- PMA number
- P950021
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAYER ADVIA IMS PSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-07-16
- Decision date
- 2003-09-02
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL OF THE IMMUNO 1 PROSTATE SPECIFIC ANTIGEN (PSA) ON THE ADVIA INTEGRATED MODULAR SYSTEM (IMS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) AND IS INDICATED FOR: THE ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) METHOD IS FOR IN VITRO DIAGNOSTIC USE TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF THE SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN
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