|Trade Name||VERSANT HCV RNA 3.0 ASSAY (BDNA)|
|Classification Name||assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|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.