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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 CMV
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP210022
Supplement NumberS008
Date Received10/18/2023
Decision Date01/16/2024
Reclassified Date10/23/2024
Product Code PAB 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change of the Alinity m CMV Assay to implement a new application specification file containing an improved PCR reagent assembly process that mitigates the potential for overflow at the Alinity m Amplification (AMP) Tray, thus minimizing the potential risk for carryover. The Alinity m CMV Kit package insert is also being updated to reflect the carryover rate using the new application specification file.
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