This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the diasorin eti-core-igmk plus assay. The device is indicated for: eti-core-igmk plus is an in vitro enzyme immunoassay(eia) intended for use in the qualitative determination of igm antibody to hepatitis b core antigen (igm anti-hbc) in human serum or plasma (edta, citrate or heparin). The eti-core-igmk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The presence of igm anti-hbc, in the presence of total antibody to hbc (anti-hbc) is indicative of a laboratory diagnosis for acute infection. The absence of igm anti-hbc, in the presence of total anti-hbc, is indicative of a laboratory diagnosis for recovery from hbv infection. Further hbv serological marker testing is required to define the specific disease state. The eti-core-igmk plus assay's performance has not been established for the monitoring of hbv disease or therapy. This assay has not been fda-approved for the screening of blood or plasma donors.
| Device | DIASORIN ETI-CORE-IGMK PLUS ASSAY |
| Applicant | DIASORIN, INC. |
| Date Received | 1999-07-02 |
| Decision Date | 2001-03-30 |
| Notice Date | 2001-10-09 |
| PMA | P990044 |
| Supplement | S |
| Docket Number | 01M-0455 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990044 | Original Filing | |
| S029 | 2021-11-23 | 30-day Notice |
| S028 | 2020-07-16 | 30-day Notice |
| S027 | 2019-08-28 | 30-day Notice |
| S026 | 2019-06-18 | 30-day Notice |
| S025 | 2018-05-30 | 30-day Notice |
| S024 | 2018-03-30 | 30-day Notice |
| S023 | ||
| S022 | 2018-02-14 | 30-day Notice |
| S021 | 2017-09-18 | 30-day Notice |
| S020 | 2017-04-25 | 30-day Notice |
| S019 | 2017-03-29 | 30-day Notice |
| S018 | 2016-05-10 | 30-day Notice |
| S017 | 2014-06-05 | 30-day Notice |
| S016 | 2013-12-27 | 30-day Notice |
| S015 | 2013-06-05 | 30-day Notice |
| S014 | 2012-11-09 | Special (immediate Track) |
| S013 | ||
| S012 | 2012-02-17 | 30-day Notice |
| S011 | 2011-10-18 | 30-day Notice |
| S010 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S009 | 2009-11-13 | Real-time Process |
| S008 | 2006-12-29 | 30-day Notice |
| S007 | 2005-06-03 | 30-day Notice |
| S006 | ||
| S005 | 2004-04-05 | 30-day Notice |
| S004 | 2003-04-14 | 30-day Notice |
| S003 | 2003-04-09 | Normal 180 Day Track No User Fee |
| S002 | 2002-10-17 | 30-day Notice |
| S001 | 2002-01-07 | Normal 180 Day Track |