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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 ANTI-HBS TEST SYSTEM
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP010054
Supplement NumberS008
Date Received04/30/2008
Decision Date10/30/2008
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXTEND APPLICATION OF THE ELECSYS HBSAG AND ELECSYS ANTI-HBS TEST SYSTEMS ONTO THE UPDATED VERSION OF THE MODULAR ANALYTICS E170 ANALYZER KNOWN AS THE COBAS E 601 ANALYZER. WHILE THE MODULAR ANALYTICS MODULAR SYSTEM INTEGRATES THE E170 MODULE WITH CLINICAL CHEMISTRY MODULES P OR D, THE COBAS E 601 IMMUNOASSAY ANALYZER IS A COMPONENT OF THE C6000 MODULAR SYSTEM WHICH INTEGRATES IMMUNOLOGY TESTING WITH THE COBAS C 501 CLINICAL CHEMISTRY ANALYSER. THERE HAVE BEEN NO CHANGES TO THE COMPOSITION OF ANY OF TE TEST SYSTEM REAGENTS (IMMUNOASSAY, CONTROLS OR CONFIRMATORY TEST), THE APPLICATION PARAMETERS, THE ANALYZER¿S ANALYTICAL MEASURING COMPONENT OR HOW THE RESULTS ARE CALCULATED. THE INDICATIONS FOR USE OF THE TWO TEST SYSTEMS REMAIN THE SAME.
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