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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 NameABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP100017
Date Received05/18/2010
Decision Date05/17/2011
Product Code
MZP[ Registered Establishments with MZP ]
Docket Number 11M-0349
Notice Date 05/20/2011
Advisory Committee Microbiology
Clinical Trials NCT00202839
NCT00351403
NCT00361179
NCT00629967
NCT00687999
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
The approval of realtime hcv, abbott realtime hcv amplification reagent kit, abbott realtime hcv control kit, abbott realtime hcv calibrator kit, and optional ung uracil-n-glycosylase (ung) for use in conjunction with abbott realtime hcv. This device is indicated for: abbott realtime hcv amplification reagent kit, the abbott real time hcv assay is an in vitro reverse transcription- polymerase chain reaction (rt-pcr) assay for use with the abbott msample preparation system reagents and with the abbott m2000sp and m2000ry4 instruments for the quantitation of hepatitis c viral (hcv) rna in human serum or plasma (edta) from hcv-infected individuals. Specimens containing hcv genotypes 1-6 have been validated for quantitation in the assay. The abbott realtime hcv assay is intended for use as an aid in the management of hcv-infected patients undergoing antiviral therapy. The assay measures hcv rna levels at baseline and during treatment and can be utilized to predict sustained and non- sustained virological response to hcv therapy. The results from the realtime hcv assay 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 or 2b plus ribavirin. No information is available on the assays predictive value when other therapies are used. Assay performance for determining the state of hcv infection has not been established. The abbott realtime hcv assay is not for screening blood, plasma, serum or tissue donors for hcv, or to be used as a diagnostic test to confirm the presence of hcv infection. Abbott realtime hcv control kit, the abbott realtime hcv controls are used to establish run validity of the abbott realtime hcv assay when used for the quantitation of hepatitis c virus (hcv) rna in human serum and plasma (edta) from hcv infected individuals. For additional info refer to approval order.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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