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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 AND TOTAL PSA CALSET
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP990056
Supplement NumberS003
Date Received02/13/2006
Decision Date08/10/2006
Product Code MTF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR FORMULATION CHANGE TO THE HAMA INTERFERENCE REDUCTION PROTEINS TO IMPROVE ASSAY ROBUSTNESS WITH REGARD TO POTENTIAL HAMA INTERFERENCE FOR THE ELECSYS TOTAL PSA IMMUNOASSAY AND CHANGES IN MATRIX, ANTIGEN AND CALIBRATOR 1 TARGET VALUE FOR THE ELECSYS TOTAL PSA CALSET. THE ELECSYS TOTAL PSA CALSET, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, ELECSYS TOTAL PSA CALSET II.
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