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Device | ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S017 |
Date Received | 08/19/2002 |
Decision Date | 11/27/2002 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA TO AID IN THE PROGNOSIS AND MANAGEMENT OF PATIENTS WITH PROSTATE CANCER. |