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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® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
Generic NameCytomegalovirus (cmv) dna quantitative assay
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP110037
Date Received10/24/2011
Decision Date07/05/2012
Product Code PAB 
Docket Number 12M-0713
Notice Date 07/11/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST. THIS DEVICE IS INDICATED FOR: THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMENPROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID-ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. IN THIS POPULATION SERIAL DNA MEASUREMENTS CAN BE USED TO ASSESS VIROLOGICAL RESPONSE TO ANTIVIRAL TREATMENT. THE RESULTS FROM THE COBAS AMPLIPREP/COBAS TAQMAN CMVTEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS NOT INTENDED FOR USE 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 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 
S060 S061 S062 
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