This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for revision of the intended use to include use of the vitros 5600integrated system and vitros 3600 immunodiagnostic system with the vitrosimmunodiagnostic products anti-hbs assay. The device, as modified, will be marketed underthe trade names vitros immunodiagnostic products anti-hbs quantitative reagent pack,vitros immunodiagnostic products anti-hbs calibrator, and is indicated for:vitros immunodiagnostic products anti-hbs quantitative reagent pack:for the quantitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serum using the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus(hbv) infection for individuals prior to or following hbv vaccination, or where vaccinationstatus is unknown. Assay results may be used with other hbv serological markers for thelaboratory' diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis, in whometiology is unknown. Vitros immunodiagnostic products anti-hbs calibrator:for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system for the quantitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serumusing the vitros immunodiagnostic products anti-hbs quantitative reagent pack.
| Device | VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR |
| 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 | 2009-09-04 |
| Decision Date | 2010-01-11 |
| PMA | P000014 |
| Supplement | S019 |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000014 | Original Filing | |
| S036 | 2020-09-22 | 30-day Notice |
| S035 | 2019-05-21 | 30-day Notice |
| S034 | 2018-10-16 | Normal 180 Day Track No User Fee |
| S033 | 2018-02-21 | Normal 180 Day Track No User Fee |
| S032 | 2018-01-09 | Normal 180 Day Track No User Fee |
| S031 | 2015-08-10 | 30-day Notice |
| S030 | 2015-06-25 | 30-day Notice |
| S029 | 2015-06-24 | Normal 180 Day Track |
| S028 | 2014-11-14 | 30-day Notice |
| S027 | 2014-02-14 | 30-day Notice |
| S026 | 2012-10-17 | 30-day Notice |
| S025 | 2012-02-15 | 30-day Notice |
| S024 | 2011-10-05 | Real-time Process |
| S023 | 2011-02-14 | 30-day Notice |
| S022 | 2010-10-18 | 30-day Notice |
| S021 | 2010-07-27 | 30-day Notice |
| S020 | 2009-12-01 | Normal 180 Day Track No User Fee |
| S019 | 2009-09-04 | Normal 180 Day Track |
| S018 | 2009-03-06 | 30-day Notice |
| S017 | 2008-11-13 | Normal 180 Day Track No User Fee |
| S016 | 2008-01-23 | 30-day Notice |
| S015 | 2007-05-11 | 30-day Notice |
| S014 | 2006-05-12 | 30-day Notice |
| S013 | 2005-11-21 | 30-day Notice |
| S012 | 2005-05-09 | 30-day Notice |
| S011 | 2005-03-01 | 30-day Notice |
| S010 | 2004-10-26 | 30-day Notice |
| S009 | 2004-09-15 | Real-time Process |
| S008 | 2004-07-07 | 30-day Notice |
| S007 | 2004-05-05 | 30-day Notice |
| S006 | 2003-06-16 | 30-day Notice |
| S005 | 2003-01-30 | 30-day Notice |
| S004 | 2001-03-26 | Normal 180 Day Track |
| S003 | 2001-03-22 | 30-day Notice |
| S002 | 2001-03-12 | 135 Review Track For 30-day Notice |
| S001 | 2001-03-05 | 30-day Notice |