ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
FDA premarket approval P970038/S005 · decided 2002-11-27
Approval details
- PMA number
- P970038
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2002-08-19
- Decision date
- 2002-11-27
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER. THE DEVICE IS INDICATED FOR: THE ACCESS HYBRITECH FREE PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. ACCESS HYBRITECH FREE PSA IS INTENDED TO BE USED WITH HYBRITECH (TOTAL) PSA TO CALCULATE THE RATIO OF FREE PSA TO TOTAL PSA EXPRESSED AS A PERCENTAGE (PERCENT FREE
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