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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP990056
Supplement NumberS001
Date Received10/09/2001
Decision Date02/08/2002
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
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