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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOBAS TAQMAN HCV TEST VERSION 2.0
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP060030
Supplement NumberS006
Date Received01/15/2010
Decision Date09/01/2010
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manual specimen preparation option to the currently approved automated sample preparation method. The device, as modified, will be marketed under the trade name cobas taqman hcv test, v2. 0 for use with the high pure system and is indicated for: the cobas taqman hcv test, v2. 0 for use with the high pure system is an in vitro nucleic acid amplification test for the quantitation of hepatitis c virus (hcv) rna in human plasma or serum of hcv-infected individuals using the high pure system viral nucleic acid kit for manual specimen preparation and the cobas05 taqman 48 analyzer for automated amplification and detection. Specimens containing hcv genotypes 1 through 6 have been validated for quantitation in the assay. The cobas taqman hcv test, v2. 0 for use with the high pure system is intended for use as an aid in the management of hcv-infected individuals undergoing anti-viral therapy. The assay measures hcv rna levels at baseline and during treatment and can be used to predict sustained and non-sustained virological response to hcv therapy. The results from the cobas taqman hcv test, v2. 0 for use with the high pure system must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a plus ribavirin. No information is available on the assay's predictive value when other therapies are used. Assay performance for determining the state of hcv infection has not been established.
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