Approval for the aptima hcv quant dx. This device is indicated for: the aptima hcv quant dx assay is a real-time transcription mediated amplification test (tma) used for both detection and quantitation of hepatitis c virus (hcv) rna in fresh and frozen human serum and plasma from hcv-infected individuals. Plasma may be prepared in ethylenediaminetetraacetic acid (edta), anticoagulant citrate dextrose (acd) solution, and plasma preparation tubes (ppt). Serum may be prepared in serum tubes and serum separator tubes (sst). Specimens are tested using the panther system for automated specimen processing, amplification, detection, and quantitation. Specimens containing hcv genotypes 1 to 6 are validated for detection and quantitation in the assay. The aptima hcv quant dx assay is indicated for use as an aid in the diagnosis of active hcv infection in the following populations: individuals with antibody evidence of hcv infection with evidence of liver disease, individuals suspected to be actively infected with hcv antibody evidence, and individuals at risk for hcv infection with antibodies to hcv. Detection of hcv rna indicates that the virus is replicating and, therefore, is evidence of active infection. Detection of hcv rna does not discriminate between acute and chronic state of infection. The aptima hcv quant dx assay is also indicated for use as an aid in the management of hcv infected patients undergoing hcv antiviral drug therapy. The assay can be used to measure hcv rna levels periodically prior to, during, and after treatment to determine sustained virological response (svr) or nonsustained virological response (nsvr). Assay performance characteristics have been established for individuals infected with hcv and treated with certain direct acting antiviral agents (daa) regimens. No information is available on the assay’s predictive value when other therapies are used. The results from the aptima hcv quant dx assay must be interpreted within the context of all relevant clinical and laboratory findings. The aptima hcv quant dx assay is not approved for use as a screening test for the presence of hcv rna in blood or blood products.
| Device | APTIMA HCV QUANT DX ASSAY |
| 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 | HOLOGIC, INC. |
| Date Received | 2016-07-08 |
| Decision Date | 2017-02-13 |
| Notice Date | 2017-02-27 |
| PMA | P160023 |
| Supplement | S |
| Product Code | MZP |
| Docket Number | 17M-0971 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 10210 Genetic Center Dr san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160023 | | Original Filing |
| S019 |
2020-07-09 |
30-day Notice |
| S018 | | |
| S017 |
2020-02-12 |
30-day Notice |
| S016 |
2019-12-23 |
Real-time Process |
| S015 |
2019-06-21 |
Normal 180 Day Track |
| S014 |
2019-05-21 |
30-day Notice |
| S013 |
2019-04-19 |
30-day Notice |
| S012 |
2019-03-27 |
30-day Notice |
| S011 |
2019-03-18 |
Real-time Process |
| S010 |
2019-02-21 |
30-day Notice |
| S009 |
2018-12-31 |
Real-time Process |
| S008 |
2018-11-29 |
30-day Notice |
| S007 |
2018-10-03 |
30-day Notice |
| S006 |
2018-08-31 |
30-day Notice |
| S005 |
2018-07-09 |
30-day Notice |
| S004 |
2018-05-09 |
135 Review Track For 30-day Notice |
| S003 |
2018-04-20 |
30-day Notice |
| S002 |
2018-03-12 |
30-day Notice |
| S001 |
2017-08-28 |
Normal 180 Day Track |
NIH GUDID Devices