Approval for revision of the intended use to include use of the vitros 5600integrated system and vitros 3600 immunodiagnostic system with the anti-hbc igm assay. The device, as modified, will be marketed under the trade name vitros immunodiagnosticproducts anti-hbc igm reagent pack, vitros immunodiagnostic products anti-hbccalibrator and is indicated for:vitros immunodiagnostic products anti-hbc igm reagent pack:for the in vitro qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm)in human adult and pediatric serum and plasma (heparin, edta and citrate) and neonate serumusing the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnosticsystem and the vitros 5600 integrated system. Assay results, in conjunction with other serological and clinical information, may be used for thelaboratory diagnosis of individuals with acute or chronic hepatitis b. Vitros immunodiagnostic products anti-hbc igm calibrator:for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros3600 immunodiagnostic system and the vitros 5600 integrated system when used for the invitro qualitative detection of igm antibody to hepatitis b virus core antigen (anti-hbc igm) inhuman adult and pediatric serum and plasma (edta, heparin or citrate) and neonate serum using vitros anti-hbc igm reagent packs. The vitros anti-hbc igm calibrator has been validated for use only on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and thevitros 5600 integrated system with the vitros immunodiagnostic products anti-hbc igm reagent packs.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM 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, Inc. |
| Date Received | 2009-02-20 |
| Decision Date | 2009-07-15 |
| PMA | P030026 |
| Supplement | S016 |
| 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 |
|---|
| P030026 | | Original Filing |
| S037 |
2022-09-30 |
Real-time Process |
| S036 |
2019-05-21 |
30-day Notice |
| S035 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S034 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S033 |
2018-01-16 |
30-day Notice |
| S032 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S031 |
2015-10-05 |
30-day Notice |
| S030 |
2015-08-10 |
30-day Notice |
| S029 |
2015-01-16 |
30-day Notice |
| S028 |
2013-09-20 |
30-day Notice |
| S027 |
2012-11-29 |
30-day Notice |
| S026 |
2012-10-17 |
30-day Notice |
| S025 |
2012-01-30 |
30-day Notice |
| S024 |
2011-10-05 |
Real-time Process |
| S023 |
2011-05-19 |
30-day Notice |
| S022 |
2011-05-16 |
135 Review Track For 30-day Notice |
| S021 |
2010-12-08 |
30-day Notice |
| S020 |
2010-10-18 |
30-day Notice |
| S019 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S018 |
2009-05-22 |
30-day Notice |
| S017 |
2009-03-06 |
30-day Notice |
| S016 |
2009-02-20 |
Normal 180 Day Track |
| S015 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S014 |
2008-02-27 |
30-day Notice |
| S013 |
2007-03-08 |
30-day Notice |
| S012 |
2007-02-07 |
Special (immediate Track) |
| S011 |
2006-08-21 |
30-day Notice |
| S010 |
2006-05-17 |
30-day Notice |
| S009 |
2005-11-14 |
30-day Notice |
| S008 |
2005-09-30 |
Special (immediate Track) |
| S007 |
2005-06-27 |
30-day Notice |
| S006 |
2005-06-03 |
30-day Notice |
| S005 |
2005-04-07 |
30-day Notice |
| S004 |
2004-12-21 |
30-day Notice |
| S003 |
2004-12-15 |
30-day Notice |
| S002 |
2004-10-26 |
30-day Notice |
| S001 |
2004-05-24 |
30-day Notice |
NIH GUDID Devices