Approval for revision of the intended use to include use of the vitros 5600integrated system and vitros 3600 immunodiagnostic system with the anti-hcv assay. The device, as modified, will be marketed under the trade name vitros immunodiagnostic products anti-hcv reagent pack, vitros immunodiagnostic products anti-hcv calibrator and isindicated for:vitros immunodiagnostic products anti-hcv reagent pack:for the in vitro qualitative detection of immunoglobulin g antibody to hepatitis c virus (anti-hcv) in human serum and plasma (heparin, edta and sodium citrate) using the vitroseci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and thevitros 5600 integrated system. Three recombinant hepatitis c virus encoded antigens are used. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis c virus, (state or associated disease not determined), in persons with signs or symptoms of hepatitis and in persons at risk forhepatitis c infection. In addition, this assay may be used to screen for hepatitis c infection inpregnant women to identify neonates who are at high risk of acquiring hcv during the prenatalperiod. Vitros immunodiagnostic products anti-hcv 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 in vitroqualitative detection of immunoglobulin g antibody to hepatitis c virus (anti-hcv) in human serum and plasma (heparin, edta and sodium citrate) using vitros anti-hcv reagent packs. The vitros anti-hcv calibrator has been validated for use only on the vitros eci/eciqimmunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600integrated system with the vitros immunodiagnostic products anti-hcv reagent pack.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Date Received | 2009-03-30 |
| Decision Date | 2009-07-15 |
| PMA | P010021 |
| Supplement | S016 |
| Product Code | MZO |
| 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 |
|---|
| P010021 | | Original Filing |
| S033 |
2020-07-20 |
30-day Notice |
| S032 |
2019-05-21 |
30-day Notice |
| S031 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S030 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S029 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S028 |
2016-10-21 |
30-day Notice |
| S027 |
2015-08-10 |
30-day Notice |
| S026 |
2015-06-25 |
30-day Notice |
| S025 |
2014-11-17 |
135 Review Track For 30-day Notice |
| S024 |
2013-02-08 |
30-day Notice |
| S023 |
2012-10-17 |
30-day Notice |
| S022 |
2012-01-30 |
30-day Notice |
| S021 |
2011-10-05 |
Real-time Process |
| S020 |
2011-06-14 |
135 Review Track For 30-day Notice |
| S019 |
2011-03-24 |
135 Review Track For 30-day Notice |
| S018 |
2010-04-26 |
30-day Notice |
| S017 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S016 |
2009-03-30 |
Normal 180 Day Track |
| S015 |
2009-03-06 |
30-day Notice |
| S014 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S013 |
2008-03-20 |
Real-time Process |
| S012 |
2008-01-23 |
30-day Notice |
| S011 |
2007-06-05 |
30-day Notice |
| S010 |
2007-03-28 |
30-day Notice |
| S009 | | |
| S008 |
2005-11-16 |
30-day Notice |
| S007 |
2005-09-16 |
Normal 180 Day Track |
| S006 |
2005-06-27 |
135 Review Track For 30-day Notice |
| S005 |
2005-02-02 |
Special (immediate Track) |
| S004 |
2004-10-26 |
30-day Notice |
| S003 |
2004-07-16 |
30-day Notice |
| S002 |
2004-07-07 |
30-day Notice |
| S001 |
2003-04-11 |
30-day Notice |
NIH GUDID Devices