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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.
 
DeviceCOBAS CMV
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP160041
Date Received09/21/2016
Decision Date06/01/2017
Reclassified Date10/23/2024
Product Code PAB 
Docket Number 17M-3430
Notice Date 06/07/2017
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the cobas CMV test - This device is indicated for:cobas® CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the management of CMV in solid organ transplant patients and in 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 cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings. cobas® CMV is not intended for use as a screening test for blood or blood products.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S001  S008 S002 S029 S012 S013 S024 S030 S027 S014 S021 
S022 S032 S035 S034 S033 S039 S040 S042 S006 S007 S003 S004 
S009 S010 S011 S005 S015 S016 S025 S026 S028 S031 S023 S017 
S018 S019 S020 S041 S043 S044 S045 S046 S036 S037 S038 
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