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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.
 
DeviceBAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
725 POTTER STREET
BERKELEY, CA 94710
PMA NumberP020022
Date Received06/19/2002
Decision Date03/28/2003
Withdrawal Date 02/26/2015
Product Code MZP 
Docket Number 04M-0538
Notice Date 12/08/2004
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA). THE DEVICE IS INDICATED FOR: THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA (EDTA AND ACD) OF HCV-INFECTED INDIVIDUALS USING THE BAYER SYSTEM 340 BDNA ANALYZER. SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY. THE VERSANT HCV RNA 3.0 ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND ARE USEFUL IN PREDICTING NON-RESPONSE TO HCV THERAPY, AND ARE PREDICTIVE OF NON-SUSTAINED VIROLOGICAL RESPONSE. THE RESULTS FROM THE VERSANT HCV RNA 3.0 ASSAY (BDNA) MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED ONLY FOR INDIVIDUALS TREATED WITH INTERFERON ALFA-2B PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY PREDICTIVE VALUES WHEN OTHER THERAPIES ARE USED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
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