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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAlinity m CMV
Generic NameCytomegalovirus (cmv) dna quantitative assay
ApplicantAbbott Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
PMA NumberP210022
Date Received06/01/2021
Decision Date05/05/2022
Product Code PAB 
Docket Number 22M-0773
Notice Date 05/10/2022
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for Alinity m CMV. Alinity m CMV AMP KitThe Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate cytomegalovirus (CMV) DNA in human EDTA plasma. The Alinity m CMV assay is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant and Solid Organ Transplant patients who are undergoing anti-cytomegalovirus therapy. The Alinity m CMV assay can be used to assess virological response to anti-cytomegalovirus therapy. The results from the Alinity m CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The Alinity m CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products.Alinity m CTRL KitThe Alinity m CMV controls are for validity determination of the quantitative Alinity m CMV assay on the automated Alinity m System. These controls are intended to be used with the Alinity m CMV assay; refer to the assay package insert for additional information.Alinity m CAL KitThe Alinity m CMV calibrators are for calibration for the Alinity m CMV assay on the automated Alinity m System when used for the quantitative determination of CMV DNA. The calibrators are intended to be used with the Alinity m CMV assay; refer to the assay package insert for additional information.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 
S013 
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