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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.
 
DeviceABBOTT REALTIME CMV
Generic Namecytomegalovirus (cmv) dna quantitative assay
ApplicantABBOTT MOLECULAR
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP160044
Date Received10/04/2016
Decision Date05/18/2017
Product Code PAB 
Docket Number 17M-3200
Notice Date 06/01/2017
Advisory Committee Microbiology
Clinical TrialsNCT01877655
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Abbott RealTime CMV test is an in vitro polymerase chain reaction (PCR) assay for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma. The Abbott RealTime CMV test is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant patients who are undergoing anti-cytomegalovirus therapy. In this population, serial DNA measurement can be used to assess virological response to anti-cytomegalovirus therapy. The results from the RealTime CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The RealTime CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 
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