Approval for the abbott realtime hcv genotype ii, abbott realtime hcv genotype ii control kit, and uracil-glycosylase(ung). This device is indicated for: abbott realtime hcv genotype iithe abbott realtime hcv genotype ii 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 m2000rt instruments for the qualitative identification ofhepatitis c virus (hcv) genotypes 1, 1a, 1b, and 2 - 5 in plasma or serum from individuals chronically infected with hcv. The abbott realtime hcv genotype ii is intended for use as an aid in the management of hcv-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with hcv, are being considered for antiviral treatment, and are positive for hcv rna. The abbott realtime hcv genotype ii assay is not for screening blood, plasma, serum or tissue donors for hcv. Abbott realtime hcv genotype ii control kitthe abbott realtime hcv genotype ii controls are used to establish run validity of the abbott realtime hcv genotype ii assay when used for determining the genotype(s) of hepatitis c virus (hcv) in plasma or serum from individuals chronically infected with hcv. Uracil-n-glycosylase (ung) the uracil-n-glycosylase (ung) procedure is to be used in conjunction with abbott realtime hcv genotype ii assay as an optional contamination control for customer laboratories that are currently using or have previously used amplification technologies thatincorporate uracil into the amplification product.
| Device | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) |
| Classification Name | Assay, Genotyping, Hepatitis C Virus |
| Generic Name | Assay, Genotyping, Hepatitis C Virus |
| Applicant | ABBOTT MOLECULAR |
| Date Received | 2012-07-12 |
| Decision Date | 2013-06-20 |
| Notice Date | 2013-06-24 |
| PMA | P120012 |
| Supplement | S |
| Product Code | OBF |
| Docket Number | 13M-0758 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 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 |
|---|
| P120012 | | Original Filing |
| S019 |
2021-02-05 |
30-day Notice |
| S018 |
2019-04-10 |
30-day Notice |
| S017 |
2018-05-25 |
30-day Notice |
| S016 |
2017-06-27 |
135 Review Track For 30-day Notice |
| S015 |
2016-12-01 |
30-day Notice |
| S014 |
2016-06-01 |
30-day Notice |
| S013 |
2016-04-20 |
30-day Notice |
| S012 |
2016-03-28 |
30-day Notice |
| S011 |
2016-03-25 |
30-day Notice |
| S010 |
2015-12-16 |
Real-time Process |
| S009 |
2015-07-29 |
Real-time Process |
| S008 | | |
| S007 |
2015-03-26 |
30-day Notice |
| S006 |
2014-11-10 |
30-day Notice |
| S005 |
2014-10-24 |
30-day Notice |
| S004 |
2014-08-28 |
30-day Notice |
| S003 |
2013-07-23 |
30-day Notice |
| S002 |
2013-07-15 |
30-day Notice |
| S001 |
2013-07-12 |
30-day Notice |
NIH GUDID Devices