Approval for the alinity m hcv. The assay is an in vitro reverse transcription-polymerase chain reaction (rt-pcr) assay for both the detection and quantitation of hepatitis c virus (hcv) rna, in human plasma (edta, acid citrate dextrose) or serum, from hcv antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active hcv infection in individuals with antibody evidence of hcv infection, and to aid in the management of patients with known active hcv infection, including svr determination. The results from the alinity m hcv assay must be interpreted within the context of all relevant clinical and laboratory findings. The alinity m hcv assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for hcv.
| Device | Alinity m HCV |
| Generic Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | Abbott Molecular, Inc. |
| Date Received | 2019-09-30 |
| Decision Date | 2020-03-23 |
| PMA | P190025 |
| Supplement | S |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular, Inc. 1300 E. Touhy Avenue des Plaines, IL 60018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190025 | Original Filing | |
| S006 | 2021-04-15 | Real-time Process |
| S005 | 2021-02-05 | 30-day Notice |
| S004 | ||
| S003 | 2020-12-21 | 30-day Notice |
| S002 | 2020-05-07 | 30-day Notice |
| S001 | 2020-04-06 | 30-day Notice |