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. |
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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 |
Supplement Number | S003 |
Date Received | 02/13/2006 |
Decision Date | 08/10/2006 |
Product Code |
MTF |
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 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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