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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.
 
DeviceVERSANT 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
Supplement NumberS006
Date Received02/22/2007
Decision Date12/14/2007
Withdrawal Date 02/26/2015
Product Code MZP 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE VERSANT 440 MOLECULAR SYSTEM (SYSTEM 400). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA AND IS INDICATED FOR: THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE DIRECT QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA OF HCV INFECTED INDIVIDUALS USING THE SYSTEM 340 BDNA ANALYZER OR THE VERSANT 440 MOLECULAR SYSTEM. SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY. THE VERSANT HCV RNA 3.0 ASSAY (BDNA) 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 IS USEFUL IN PREDICTING NON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. 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?S PREDICTIVE VALUES WHEN OTHER THERAPIES ARE USED.
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