Approval for the aptima hbv quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human plasma and serum on the fully automated panther® system. Plasma may be prepared in ethylenediaminetetraacetic acid (edta), anticoagulant citrate dextrose (acd) solution, and plasma preparation tubes (ppts). Serum may be prepared inserum tubes and serum separator tubes (ssts). Specimens are tested using the fullyautomated panther system for sample processing, amplification, and quantitation. Specimenscontaining hbv genotypes a, b, c, d, e, f, g, and h are validated for quantitation in the assay. The aptima hbv quant assay is intended for use as an aid in the management of patientswith chronic hbv infections undergoing hbv antiviral drug therapy. The assay can be usedto measure hbv dna levels at baseline and during treatment to aid in assessing viralresponse to treatment. The results from the aptima hbv quant assay must be interpretedwithin the context of all relevant clinical and laboratory findings. Assay performance fordetermining the clinical stage of hbv infection has not been established. Clinicalperformance characteristics have been established for individuals treated with tenofovirdisoproxil fumarate or entecavir. The aptima hbv quant assay is not approved for use as a screening test for the presenceof hbv dna in blood or blood products or as a diagnostic test to confirm the presence ofhbv infection.
| Device | Aptima HBV Quant Assay |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Hologic, Inc |
| Date Received | 2017-07-31 |
| Decision Date | 2018-01-23 |
| Notice Date | 2018-02-02 |
| PMA | P170025 |
| Supplement | S |
| Product Code | MKT |
| Docket Number | 18M-0411 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Hologic, Inc 10210 Genetic Center Drive san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170025 | | Original Filing |
| S018 |
2022-06-16 |
30-day Notice |
| S017 |
2021-12-14 |
Real-time Process |
| S016 |
2020-07-09 |
30-day Notice |
| S015 |
2020-02-12 |
30-day Notice |
| S014 |
2019-12-23 |
Real-time Process |
| S013 |
2019-06-21 |
Normal 180 Day Track |
| S012 |
2019-04-19 |
30-day Notice |
| S011 |
2019-03-27 |
30-day Notice |
| S010 |
2019-03-18 |
Real-time Process |
| S009 |
2019-02-21 |
30-day Notice |
| S008 |
2019-01-31 |
30-day Notice |
| S007 |
2018-12-31 |
Real-time Process |
| S006 |
2018-11-29 |
30-day Notice |
| S005 |
2018-10-03 |
30-day Notice |
| S004 |
2018-05-11 |
135 Review Track For 30-day Notice |
| S003 |
2018-04-20 |
30-day Notice |
| S002 |
2018-03-12 |
30-day Notice |
| S001 |
2018-02-21 |
Normal 180 Day Track |
NIH GUDID Devices