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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.
 
DeviceAptima CMV Quant Assay
Generic Namecytomegalovirus (cmv) dna quantitative assay
ApplicantHologic, Inc.
10210 genetic center drive
san diego, CA 92121
PMA NumberP210029
Date Received07/26/2021
Decision Date05/09/2022
Product Code PAB 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of The Aptima CMV Quant Assay - This device is approved for:The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther system. The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from Aptima CMV Quant Assay must be interpreted within the context of all relevant clinical and laboratory findings.Aptima CMV Quant Assay is not intended for use as a screening assay for the presence of CMV in blood or blood products.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
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