Approval for the addition of a new process step to identify and dilute samples with high result signal-to-cutoff ratio (s/c) above the normal negative population and the changes involved in adding this new process. These changes are an update to the magnetic card and to the labeling of the vitros anti-hbc reagent pack to support the identification, dilution and testing of the high negative samples.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND 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 |
| Date Received | 2007-12-10 |
| Decision Date | 2008-02-12 |
| PMA | P030024 |
| Supplement | S007 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHO-CLINICAL DIAGNOSTICS 100 Indigo Creek Dr. rochester, NY 14626-5101 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030024 | | Original Filing |
| S029 |
2019-05-21 |
30-day Notice |
| S028 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S027 |
2018-09-17 |
30-day Notice |
| S026 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S025 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S024 |
2017-08-07 |
30-day Notice |
| S023 |
2015-08-10 |
30-day Notice |
| S022 |
2015-06-25 |
30-day Notice |
| S021 |
2013-08-12 |
30-day Notice |
| S020 |
2012-10-17 |
30-day Notice |
| S019 |
2012-05-04 |
30-day Notice |
| S018 |
2012-01-30 |
30-day Notice |
| S017 |
2011-10-05 |
Real-time Process |
| S016 |
2011-05-16 |
135 Review Track For 30-day Notice |
| S015 |
2011-04-15 |
30-day Notice |
| S014 |
2010-12-06 |
135 Review Track For 30-day Notice |
| S013 |
2010-10-18 |
30-day Notice |
| S012 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S011 |
2009-03-06 |
30-day Notice |
| S010 |
2009-02-12 |
Normal 180 Day Track |
| S009 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S008 |
2008-01-23 |
30-day Notice |
| S007 |
2007-12-10 |
Real-time Process |
| S006 |
2007-05-11 |
30-day Notice |
| S005 |
2006-05-15 |
30-day Notice |
| S004 |
2005-11-14 |
30-day Notice |
| S003 |
2005-04-08 |
Special (immediate Track) |
| S002 |
2004-10-26 |
30-day Notice |
| S001 |
2004-03-17 |
30-day Notice |
NIH GUDID Devices