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Device | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P990056 |
Date Received | 10/04/1999 |
Decision Date | 11/22/2000 |
Product Code |
MTF |
Docket Number | 00M-1660 |
Notice Date | 12/12/2000 |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ELECSYS(R) TOTAL PSA IMMUNOASSAY AND ELECSYS(R) TOTAL PSA CALSET. THE DEVICE, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DOGOTA; RECTAL EXAM (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 PROSTATE CANCER. THE TEST ID FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS. THE ELECTOCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS(R) 1010 AND 2010 IMMUNOASSAY ANALYZERS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S043 |