Approval for revision of the intended use to include use of the vitros 5600 integrated system and vitros 3600 immunodiagnostic system with the vitros hbsag assay and the vitros hbsag confirmatory kit. These devices, as modified, will be marketed under the trade name vitros immunodiagnostic products hbsag reagent pack, vitros immunodiagnostic products hbsag calibrator and vitros immunodiagnostic products hbsag confirmatory kit and is indicated for: vitros immunodiagnostic products hbsag reagent pack:for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum andplasma (heparin, edta, and sodium citrate) using the vitros eci/eciq immunodiagnosticsystems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute and chronic hepatitis b. In addition, this assaymay be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring iibv during the perinatal period. Vitros immunodiagnostic products hbsag calibralor: for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros3600 immunodiagnostic system and the vitros 5600 integrated system for the in vitroqualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma using vitros hbsag reagent packs. The vitros hbsag calibrator has been validated for use only on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnosticsystem and the vitros 5600 integrated system with the vitros immunodiagnostic productsanti-hbc reagent packs. (see approval order for additional approval information)
| Device | VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Date Received | 2009-02-02 |
| Decision Date | 2009-10-23 |
| PMA | P000044 |
| Supplement | S020 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101 |
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