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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-HBC Immunoassay test system
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP100032
Supplement NumberS014
Date Received02/21/2017
Decision Date08/16/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) the inclusion of a second antigen source for the recombinant hepatitis B core antigen used in Reagent 1 of the test kit; 2) an update in the device by changing the standardization traceability to the World Health Organization Standard NIBSC 95/522; 3) extension of the reagent rackpack onboard stability from 4 weeks to 8 weeks; 4) addition of K3-EDTA plasma as a specimen type; and 5) modification of the device name.
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