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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 HBsAg II Auto Confirm
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS, INC.
9115 HAGUE ROAD
INDIANAPOLIS, IN 46038
PMA NumberP160019
Supplement NumberS011
Date Received11/27/2019
Decision Date10/19/2020
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1) the Elecsys HBsAg II Auto Confirm: Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, lithium heparin, K2-EDTA, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg II assay. The electrochemiluminescence immunoassay ECLIA is intended for use on cobas e immunoassay analyzers;2) the PreciControl HBsAg Auto Confirm: PreciControl HBsAg Auto Confirm is used for quality control of the Elecsys HBsAg II Auto Confirm Immunoassay on the cobas e 801 immunoassay analyzer; and 3) the PreciControl HBsAg II: PreciControl HBsAg II is used for quality control of the Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm immunoassays on the cobas e immunoassay analyzers. The performance of PreciControl HBsAg II has not been established with any other HBsAg assay.
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