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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP020022
Date Received06/19/2002
Decision Date03/28/2003
Product Code
MZP[ Registered Establishments with MZP ]
Docket Number 04M-0538
Notice Date 12/08/2004
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S011 
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