Approval for the abbottrealtime hbv. The device is indicated for:abbott realtime hbv assay:abbott realtime hbv assay is an in vitro polymerase chain reaction (pcr) assay for use with the abbott m2000 systemdna reagents and with the abbott m200sp and m2ooort instrumentsfor the quantitation of hepatitis b virus (hbv) dna in human serum or plasma (edta) from chronically hbv-infected individuals. The assay is intended for use as an aid in themanagement 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 abbott realtime hbv assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of hbv infection has not been established. Clinical performancecharacteristics have been established for individuals treated with adefovir dipivoxil. This assayis not intended for use as a screening test in blood or blood products for hbv or as a diagnostic test to confirm the presence of hbv infection. Abbott realtime hbv assay control kit:the abbott realtime hbv controls arc used to establish run validity of the abbott realtimehbv assay when used for the quantitation of hepatitis b virus (hbv) dna in human serumand plasma (edta) from hbv infected individuals. Abbott realtime hbv assay calibrator kit:the abbott realtime hbv calibrators are for calibration of the abbott realtime hbv assay when used for the quantitation determination of hepatitis b virus (hbv) dna in human serum and plasma (edta) from hbv infected individuals.
| Device | ABBOTT REALTIME HBV ASSAY |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2008-10-16 |
| Decision Date | 2010-08-13 |
| Notice Date | 2010-10-01 |
| PMA | P080026 |
| Supplement | S |
| Product Code | MKT |
| Docket Number | 10M-0519 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR, INC. 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 |
|---|
| P080026 | | Original Filing |
| S024 |
2021-02-05 |
30-day Notice |
| S023 |
2020-11-16 |
30-day Notice |
| S022 |
2019-04-10 |
30-day Notice |
| S021 |
2017-06-27 |
135 Review Track For 30-day Notice |
| S020 |
2016-12-01 |
30-day Notice |
| S019 |
2016-11-16 |
30-day Notice |
| S018 |
2016-10-27 |
30-day Notice |
| S017 |
2016-03-28 |
30-day Notice |
| S016 |
2015-07-29 |
Real-time Process |
| S015 | | |
| S014 |
2015-03-26 |
30-day Notice |
| S013 |
2014-11-10 |
30-day Notice |
| S012 |
2014-10-24 |
30-day Notice |
| S011 |
2013-11-12 |
30-day Notice |
| S010 |
2013-10-21 |
30-day Notice |
| S009 |
2013-07-23 |
30-day Notice |
| S008 |
2013-07-11 |
Real-time Process |
| S007 |
2013-05-01 |
30-day Notice |
| S006 |
2013-02-15 |
Normal 180 Day Track |
| S005 |
2012-12-26 |
30-day Notice |
| S004 |
2012-10-04 |
30-day Notice |
| S003 |
2012-04-02 |
135 Review Track For 30-day Notice |
| S002 |
2011-07-01 |
135 Review Track For 30-day Notice |
| S001 | | |
NIH GUDID Devices