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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 m HBV
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP200013
Supplement NumberS011
Date Received12/07/2022
Decision Date12/22/2022
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition to Limitations of the Procedure: Unexpected HBV DNA levels due to carry over may occur. If results are inconsistent with patient history and other diagnostics through patient monitoring, a retest of the sample should be considered by the physician or healthcare provider. Approval is also for the following change to the Specific Performance Characteristic – Carryover section: The carryover rate for Alinity m HBV was determined in two studies. Study 1 evaluated the carryover rate in the Sample Input Rack and Sample Processing Unit by analyzing 360 valid replicates of HBV negative samples processed from alternating positions in the sample input rack with 360 valid replicates of high concentrated HBV positive samples at 100,000,000 IU/mL, across multiple runs. HBV DNA was not detected in any of the HBV negative samples, resulting in a carryover rate of 0% (95% CI: 0.0 to 1.1%). Study 2 evaluated the carryover rate in the AMP tray by evaluating 414 valid replicates of HBV negative samples processed from alternating positions at the AMP Tray with 414 valid replicates of high concentrated HBV positive samples at 100,000,000 IU/mL across multiple runs. HBV DNA was detected in 16 of the HBV negative samples resulting in a carryover rate of 3.9% (95% CI: 2.2 to 6.2%).
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