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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, PreciControl Anti-HBs
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP010054
Supplement NumberS043
Date Received08/15/2023
Decision Date01/31/2024
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of change in the name of the assay from “Elecsys Anti-HBs, PreciControl Anti-HBs, Anti-HBs CalCheck” to “Elecsys Anti-HBs, PreciControl Anti-HBs”.
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