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Device | ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P990056 |
Supplement Number | S001 |
Date Received | 10/09/2001 |
Decision Date | 02/08/2002 |
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 ADDITION OF THE ASSAY TO THE MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS TOTAL PSA IMMUNOASSAY AND ELECSYS TOTAL PSA CALSET AND ARE INDICATED AS FOLLOWS: THE ELECSYS TOTAL PSA IMMUNOASSAY, 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 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 PROSTATE CANCER. THE TEST IS FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF CANCER PATIENTS. THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS. |