Approval for the vitros immunodiagnostic products hbsag reagent pack, vitros immunodiagnostic products confirmatory kit, and vitros immunodiagnostic products calibrator. The vitros immunodiagnostics hbsag reagent pack is indicated for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (heparin, edta, and sodium citrate) using the vitros eci immunodiagnostic system. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. The vitros immunodiagnostic products hbsag calibrator is indicated for use in the calibration of the vitros immunodiagnostic system for the qualitative in vitro determination of hepatitis b surface antigen (hbsag) in human serum or plasma (heparin, edta, and sodium citrate) using vitros hbsag reagent packs. The vitros hbsag calibrator has been validated for use only on the vitros system with the vitros immunodiagnostic products hbsag reagent pack. Refer to the vitros hbsag reagent pack instructions for use for further details. The vtiros hbsag confirmatory kit is indicated for the qualitative confirmation of hepatitis b surface antigen (hbsag) in human serum and plasma (heparin, edta, and sodium citrate) specimens that have been found to be repeatedly reactive using the vitros immunodiagnostic products hbsag reagent pack and the vitros immunodiagnostic products hbsag calibrator. The vitros hbsag confirmatory kit is for use with the vitros eci immunodiagnostic system.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Date Received | 2000-11-01 |
| Decision Date | 2001-04-27 |
| Notice Date | 2001-05-14 |
| PMA | P000044 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 01M-0226 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000044 | | Original Filing |
| S040 |
2019-05-21 |
30-day Notice |
| S039 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S038 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S037 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S036 |
2017-10-17 |
30-day Notice |
| S035 |
2017-05-30 |
30-day Notice |
| S034 |
2016-03-02 |
30-day Notice |
| S033 |
2015-10-29 |
30-day Notice |
| S032 |
2015-08-10 |
30-day Notice |
| S031 |
2015-06-25 |
30-day Notice |
| S030 |
2012-10-17 |
30-day Notice |
| S029 |
2012-01-30 |
30-day Notice |
| S028 |
2011-10-05 |
Real-time Process |
| S027 |
2011-08-19 |
30-day Notice |
| S026 |
2011-04-28 |
30-day Notice |
| S025 |
2010-10-18 |
30-day Notice |
| S024 |
2010-08-06 |
30-day Notice |
| S023 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S022 |
2009-09-30 |
30-day Notice |
| S021 |
2009-03-06 |
30-day Notice |
| S020 |
2009-02-02 |
Normal 180 Day Track |
| S019 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S018 |
2008-05-15 |
30-day Notice |
| S017 |
2008-01-23 |
30-day Notice |
| S016 |
2007-03-21 |
30-day Notice |
| S015 |
2007-03-12 |
30-day Notice |
| S014 |
2006-08-08 |
30-day Notice |
| S013 |
2006-05-25 |
Real-time Process |
| S012 |
2006-05-12 |
30-day Notice |
| S011 |
2006-03-15 |
30-day Notice |
| S010 |
2005-11-18 |
30-day Notice |
| S009 |
2005-10-26 |
30-day Notice |
| S008 |
2005-09-02 |
30-day Notice |
| S007 |
2005-07-13 |
30-day Notice |
| S006 |
2005-04-08 |
Special (immediate Track) |
| S005 |
2004-11-15 |
30-day Notice |
| S004 |
2004-10-26 |
30-day Notice |
| S003 |
2003-03-06 |
30-day Notice |
| S002 |
2001-05-29 |
30-day Notice |
| S001 |
2001-05-04 |
30-day Notice |
NIH GUDID Devices