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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 HBV TEST
Generic NameHepatitis Viral B DNA Detection
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP150014
Date Received04/24/2015
Decision Date10/14/2015
Product Code MKT 
Docket Number 15M-4069
Notice Date 11/05/2015
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE COBAS HBV. THIS DEVICE IS INDICATED FOR: COBAS HBV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN EDTA PLASMA OR SERUM OF HBV-INFECTED INDIVIDUALS. THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE TEST CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM COBAS HBV MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.THE COBAS HBV IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HBV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION.
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 S055 
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