ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
FDA premarket approval P850048/S017 · decided 2002-11-27
Approval details
- PMA number
- P850048
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2002-08-19
- Decision date
- 2002-11-27
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER. THE DEVICE IS INDICATED FOR: 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 IMMUNOASSY 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
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