Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS019
Date Received09/29/2023
Decision Date06/17/2024
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 1) use of Aptima HBV Quant Assay using new estimated background minimum limits to detect, flag and invalidate test results due to a faulty lamp and 2) increase reagent on-board/off-board cycles from 5 cycles to 8 cycles
-
-