Approval for the abbott architect anti-hcv. This device is indicated for: the architect anti-hcv assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult serum and plasma (potassium edta, lithium heparin, and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hcv (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. The architect anti-hcv calibrator is used for the calibration of the architect i system when the system is used for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult serum and plasma (potassium edta, lithium heparin, and sodium heparin). The architect anti-hcv calibrator has been validated for use only on the architect i system with the architect anti-hcv reagent kit. Refer to the architect anti-hcv assay reagent package insert for the full listing of information regarding the assay. The architect anti-hcv controls are used to provide an estimation of test precision and to detect systematic analytical deviations of the architect i system (reagents, calibrator, and instrument (when the system is used for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult serum and plasma (potassium edta, lithium heparin, and sodium heparin). The architect anti-hcv controls have been validated for use only on the architect i system with the architect anti-hcv reagent kit.
| Device | ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2005-11-23 |
| Decision Date | 2006-06-07 |
| Notice Date | 2006-09-26 |
| PMA | P050042 |
| Supplement | S |
| Product Code | MZO |
| Docket Number | 06M-0389 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept 09vb abbott Park, IL 60064 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050042 | | Original Filing |
| S047 |
2021-11-18 |
30-day Notice |
| S046 |
2021-11-09 |
30-day Notice |
| S045 |
2021-02-09 |
Real-time Process |
| S044 |
2020-07-31 |
30-day Notice |
| S043 |
2020-04-08 |
30-day Notice |
| S042 | | |
| S041 | | |
| S040 | | |
| S039 |
2019-07-18 |
30-day Notice |
| S038 |
2018-12-28 |
30-day Notice |
| S037 |
2018-10-12 |
30-day Notice |
| S036 |
2018-10-10 |
30-day Notice |
| S035 |
2018-09-21 |
30-day Notice |
| S034 | | |
| S033 |
2016-02-29 |
30-day Notice |
| S032 |
2015-07-16 |
30-day Notice |
| S031 |
2014-11-13 |
30-day Notice |
| S030 |
2014-09-19 |
30-day Notice |
| S029 |
2014-04-01 |
30-day Notice |
| S028 |
2013-10-30 |
30-day Notice |
| S027 |
2013-10-28 |
30-day Notice |
| S026 |
2013-10-18 |
30-day Notice |
| S025 |
2013-08-05 |
30-day Notice |
| S024 |
2013-04-23 |
30-day Notice |
| S023 |
2013-02-15 |
30-day Notice |
| S022 |
2013-02-11 |
30-day Notice |
| S021 |
2012-11-19 |
30-day Notice |
| S020 |
2012-11-15 |
30-day Notice |
| S019 |
2012-11-13 |
30-day Notice |
| S018 |
2012-08-03 |
30-day Notice |
| S017 |
2012-07-05 |
30-day Notice |
| S016 |
2012-03-15 |
30-day Notice |
| S015 |
2011-11-23 |
Special (immediate Track) |
| S014 |
2011-10-28 |
30-day Notice |
| S013 |
2011-05-25 |
30-day Notice |
| S012 |
2011-05-04 |
Normal 180 Day Track No User Fee |
| S011 |
2011-04-18 |
30-day Notice |
| S010 |
2011-02-17 |
Normal 180 Day Track No User Fee |
| S009 |
2011-01-19 |
30-day Notice |
| S008 |
2010-12-22 |
Special (immediate Track) |
| S007 |
2010-11-01 |
Normal 180 Day Track No User Fee |
| S006 |
2010-08-02 |
Normal 180 Day Track No User Fee |
| S005 |
2009-01-28 |
Normal 180 Day Track |
| S004 |
2008-12-23 |
30-day Notice |
| S003 |
2007-10-29 |
Real-time Process |
| S002 |
2007-01-11 |
Real-time Process |
| S001 |
2006-06-08 |
135 Review Track For 30-day Notice |
NIH GUDID Devices