ACCESS HYBRITECH PSA WHO STANDARDIZATION
FDA premarket approval P850048/S021 · decided 2008-05-09
Approval details
- PMA number
- P850048
- Supplement
- S021
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH PSA WHO STANDARDIZATION
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2007-08-21
- Decision date
- 2008-05-09
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS. THE ACCESS HYBRITECH PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. THE DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPS
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