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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.
 
DeviceAptima HBV Quant Assay
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantHologic, Inc.
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP170025
Supplement NumberS001
Date Received02/21/2018
Decision Date10/02/2018
Reclassified Date10/20/2025
Product Code MKT 
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 the use of the Aptima HBV Quant Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.
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