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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.
 
DeviceMODULAR ANALYSTICS E170
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP110025
Supplement NumberS018
Date Received12/07/2016
Decision Date02/28/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of K3-EDTA plasma as a specimen type for the Elecsys Anti-HBc IgM immunoassay for use on the cobas e 411, cobas e 601, cobas e 602, and MODULAR ANALYTICS E170 analyzers.
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