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.
| Device | ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV |
| Classification Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Generic Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2010-05-18 |
| Decision Date | 2011-05-17 |
| Notice Date | 2011-05-20 |
| PMA | P100017 |
| Supplement | S |
| Product Code | MZP |
| Docket Number | 11M-0349 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100017 | | Original Filing |
| S024 |
2021-02-05 |
30-day Notice |
| S023 |
2020-11-16 |
30-day Notice |
| S022 |
2019-04-10 |
30-day Notice |
| S021 |
2018-05-25 |
30-day Notice |
| S020 |
2017-06-27 |
135 Review Track For 30-day Notice |
| S019 |
2016-12-01 |
30-day Notice |
| S018 |
2016-06-01 |
30-day Notice |
| S017 |
2016-04-20 |
30-day Notice |
| S016 |
2016-03-28 |
30-day Notice |
| S015 |
2016-03-25 |
30-day Notice |
| S014 |
2015-07-29 |
Real-time Process |
| S013 | | |
| S012 |
2015-03-26 |
30-day Notice |
| S011 |
2014-11-10 |
30-day Notice |
| S010 |
2014-10-24 |
30-day Notice |
| S009 |
2013-11-12 |
30-day Notice |
| S008 |
2013-10-21 |
30-day Notice |
| S007 |
2013-07-23 |
30-day Notice |
| S006 |
2013-05-01 |
30-day Notice |
| S005 |
2013-03-01 |
Normal 180 Day Track |
| S004 |
2013-02-04 |
30-day Notice |
| S003 |
2012-10-04 |
30-day Notice |
| S002 |
2012-04-02 |
135 Review Track For 30-day Notice |
| S001 |
2011-07-01 |
135 Review Track For 30-day Notice |
NIH GUDID Devices