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Device | ACCESS HYBRITECH PSA WHO STANDARDIZATION |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S021 |
Date Received | 08/21/2007 |
Decision Date | 05/09/2008 |
Product Code |
MTF |
Docket Number | 08M-0425 |
Notice Date | 07/25/2008 |
Advisory Committee |
Immunology |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 BIOPSY IS REQUIRED FOR THE 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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