Approval for the oraquick hcv rapid antibody test is a single-use immunoassay for the qualitative detection of antibodies to hepatitis c virus (anti-hcv) in fingerstick whole blood specimens and venipuncture whole blood specimens (edta, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The oraquick hcv rapid antibody test 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 or symptoms of hepatitis and in persons at risk for hepatitis c infection.
| Device | ORAQUICK HCV RAPID ANTIBODY TEST |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ORASURE TECHNOLOGIES INC. |
| Date Received | 2010-08-03 |
| Decision Date | 2011-02-18 |
| Notice Date | 2011-03-09 |
| PMA | P080027 |
| Supplement | S001 |
| Product Code | MZO |
| Docket Number | 11M-0132 |
| Advisory Committee | Microbiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORASURE TECHNOLOGIES INC. 220 East First Street bethlehem, PA 18015 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080027 | | Original Filing |
| S039 |
2021-03-25 |
30-day Notice |
| S038 |
2021-02-01 |
30-day Notice |
| S037 |
2020-09-14 |
30-day Notice |
| S036 | | |
| S035 |
2019-08-16 |
30-day Notice |
| S034 |
2018-11-07 |
30-day Notice |
| S033 |
2018-03-13 |
30-day Notice |
| S032 |
2018-01-08 |
30-day Notice |
| S031 |
2017-12-08 |
30-day Notice |
| S030 |
2017-09-14 |
30-day Notice |
| S029 |
2017-08-14 |
30-day Notice |
| S028 |
2017-06-07 |
30-day Notice |
| S027 |
2017-04-14 |
30-day Notice |
| S026 |
2017-01-30 |
30-day Notice |
| S025 |
2016-11-28 |
30-day Notice |
| S024 |
2016-10-24 |
30-day Notice |
| S023 |
2016-04-15 |
30-day Notice |
| S022 |
2016-02-01 |
30-day Notice |
| S021 |
2015-09-03 |
30-day Notice |
| S020 | | |
| S019 |
2014-12-23 |
30-day Notice |
| S018 |
2014-09-03 |
Special (immediate Track) |
| S017 |
2014-06-06 |
Real-time Process |
| S016 |
2014-03-04 |
Normal 180 Day Track |
| S015 |
2013-11-19 |
30-day Notice |
| S014 |
2013-09-06 |
30-day Notice |
| S013 |
2013-08-28 |
30-day Notice |
| S012 |
2013-07-12 |
Special (immediate Track) |
| S011 |
2013-04-29 |
Special (immediate Track) |
| S010 |
2013-02-21 |
30-day Notice |
| S009 |
2013-02-19 |
Special (immediate Track) |
| S008 |
2012-12-28 |
30-day Notice |
| S007 |
2012-11-28 |
Special (immediate Track) |
| S006 |
2011-04-06 |
30-day Notice |
| S005 |
2011-03-16 |
135 Review Track For 30-day Notice |
| S004 | | |
| S003 |
2011-02-23 |
135 Review Track For 30-day Notice |
| S002 | | |
| S001 |
2010-08-03 |
Panel Track |
NIH GUDID Devices