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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.
 
DeviceAlinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Dept 09v6, Bldg. Ap5-2
Abbott Park, IL 60064
PMA NumberP110029
Supplement NumberS029
Date Received08/01/2019
Decision Date01/07/2020
Reclassified Date10/20/2025
Product Code LOM 
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 migration of the ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Calibrators, ARCHITECT HBsAg Qualitative Confirmatory, and ARCHITECT HBsAg Controls onto the Alinity i Analyzer. The device, as modified, will be marketed under the trade names Alinity i HBsAg Qualitative II Reagent Kit, Alinity i HBsAg Qualitative II Calibrators, Alinity i HBsAg Qualitative II Confirmatory Reagent Kit, and Alinity I HBsAg Qualitative II Controls.
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