Approval for the alinity m hbv test. This device is indicated for:the alinity m hbv assay is an in vitro polymerase chain reaction (pcr) with fluorescent labeled probes assay for use with the automated alinity m system to quantitate hepatitis b virus (hbv) dna in human plasma and serum. The alinity m hbv assay is intended for use as an aid in the management of patients with chronic hbv infection undergoing anti-viral therapy. The assay can be used to measure hbv dna levels at baseline and during treatment to aid in assessing response to treatment. The results from the alinity m hbv assay must be interpreted within the context of all relevant clinical and laboratory findings. This assay is not intended to be used in screening blood, blood products, or cell, tissue, and cellular and tissue-based products (hct/ps), or as a diagnostic test to confirm the presence of hbv infection.
| Device | Alinity m HBV |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Abbott Molecular, Inc. |
| Date Received | 2020-03-02 |
| Decision Date | 2020-08-29 |
| PMA | P200013 |
| Supplement | S |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular, Inc. 1300 E Touhy Ave des Plaines, IL 60018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200013 | Original Filing | |
| S012 | 2022-12-20 | 30-day Notice |
| S011 | 2022-12-07 | Special (immediate Track) |
| S010 | ||
| S009 | 2022-09-21 | Special (immediate Track) |
| S008 | 2022-05-10 | 30-day Notice |
| S007 | ||
| S006 | 2022-02-17 | 30-day Notice |
| S005 | 2021-04-15 | Real-time Process |
| S004 | 2021-02-05 | 30-day Notice |
| S003 | 2021-02-05 | 30-day Notice |
| S002 | ||
| S001 | 2020-12-21 | 30-day Notice |