ABBOTT AXSYM TOTAL PSA
FDA premarket approval P910007/S005 · decided 2004-02-02
Approval details
- PMA number
- P910007
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM TOTAL PSA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Abbott Laboratories
- Date received
- 1997-09-25
- Decision date
- 2004-02-02
- Days to decision
- 2321 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT AXSYM TOTAL PSA ASSAY. THE AXSY TOTAL PSA IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE DETERMINATION OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1 ANTICHYMOTRYPSIN) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
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