Approval for the vitros immunodiagnostic products anti-hbe reagent pack, calibrator and controls. This device is indicated for: vitros immunodiagnostic products anti-hbe reagent pack for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from hbv infection, using the vitros eci/eciq immunodiagnostic systems. Further assessment of hbv infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. Vitros anti-hbe test performance has not been established for the monitoring of hbv disease or therapy. Vitros immunodiagnostic products anti-hbe calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems when used with the vitros anti-hbe test for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe). Vitros immunodiagnostic products anti-hbe controls for use in monitoring the performance of the vitros anti-hbe test when used on the vitros eci/eciq immunodiagnostic systems.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS |
| 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 | 2010-01-29 |
| Decision Date | 2011-07-20 |
| Notice Date | 2011-08-01 |
| PMA | P100001 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 11M-0563 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHO-CLINICAL DIAGNOSTICS 100 Indigo Creek Dr. rochester, NY 14626-5101 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100001 | | Original Filing |
| S017 |
2022-09-30 |
Real-time Process |
| S016 |
2019-05-21 |
30-day Notice |
| S015 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S014 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S013 |
2018-01-25 |
30-day Notice |
| S012 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S011 |
2017-08-28 |
30-day Notice |
| S010 |
2016-11-17 |
Normal 180 Day Track |
| S009 |
2016-09-12 |
30-day Notice |
| S008 |
2015-08-10 |
30-day Notice |
| S007 |
2015-06-25 |
30-day Notice |
| S006 |
2013-09-20 |
30-day Notice |
| S005 |
2012-11-29 |
30-day Notice |
| S004 |
2012-10-26 |
30-day Notice |
| S003 |
2012-10-17 |
30-day Notice |
| S002 |
2012-09-19 |
30-day Notice |
| S001 |
2012-03-22 |
30-day Notice |
NIH GUDID Devices