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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 NumberS014
Date Received12/23/2019
Decision Date01/21/2020
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.
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