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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOBAS AMPLIPREP/COBAS TAQMAN CMV TEST
Generic NameCytomegalovirus (cmv) dna quantitative assay
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP110037
Supplement NumberS001
Date Received08/07/2012
Decision Date09/05/2012
Product Code PAB 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE TEST DEFINITION FILE (TDF). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/COBAS TAQMAN CMV TEST AND IS INDICATED FOR: COBAS AMPLIPREP/COBAS TAQMAN CMV TEST THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA INHUMAN EDTA PLASMA USING THE COBAS AMPLIPRCP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE COBAS AMPLIPRCP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USC AS AN AID IN THE MANAGEMENT OFSOLID-ORGAN TRANSPLANT PATIENTS WHO ARC 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 CMV TEST 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.
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