Approval for the migration of claims from the fda approved elecsys anti-hbc igm immunoassay and elecsys precicontrol anti-hbc igm on the cobas e 601 to the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hbc igm immunoassay and elecsys precicontrol anti-hbc igm and is indicated for:elecsys anti-hbc lgm immunoassaythe elecsys anti-hbc lgm immunoassay is intended for the in vitro qualitativedetermination ofigm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, lithium heparin, sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. The presence of anti-hbc igm, in conjunction with other laboratory results and clinicalinformation, is indicative of acute or recent hepatitis b virus (hbv) infection. The elecsys anti-hbc lgm immunoassay's performance has not been established for the monitoring of hbv disease or therapy. The electrochemiluminescence immunoassay "eclia" is intended for use on the cobas e 601 and cobas e 602 immunoassay analyzers. Elecsys precicontrol anti-hbc elecsys precicontrol anti-hbc igm is used for quality control of the elecsys anti-hbc igm immunoassay on the cobas e 601 andcobas e 602 immunoassay analyzers.
| Device | ELECSYS ANTI-HBC IGM TEST SYSTEM |
| 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 | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2012-08-31 |
| Decision Date | 2013-12-20 |
| PMA | P110022 |
| Supplement | S008 |
| Product Code | LOM |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0457 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110022 | | Original Filing |
| S028 |
2021-12-02 |
30-day Notice |
| S027 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S026 |
2018-10-09 |
30-day Notice |
| S025 |
2018-04-17 |
Real-time Process |
| S024 |
2017-10-11 |
Real-time Process |
| S023 |
2017-08-03 |
30-day Notice |
| S022 |
2017-07-06 |
Normal 180 Day Track |
| S021 |
2017-05-24 |
30-day Notice |
| S020 |
2016-12-07 |
Real-time Process |
| S019 |
2016-09-07 |
Normal 180 Day Track No User Fee |
| S018 |
2016-07-11 |
135 Review Track For 30-day Notice |
| S017 |
2016-02-16 |
30-day Notice |
| S016 |
2016-01-27 |
30-day Notice |
| S015 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S014 |
2015-10-07 |
30-day Notice |
| S013 |
2014-10-16 |
Real-time Process |
| S012 |
2014-04-04 |
Real-time Process |
| S011 |
2013-07-19 |
Special (immediate Track) |
| S010 | | |
| S009 |
2012-11-30 |
30-day Notice |
| S008 |
2012-08-31 |
Normal 180 Day Track |
| S007 | | |
| S006 |
2012-02-29 |
30-day Notice |
| S005 |
2012-02-02 |
30-day Notice |
| S004 |
2012-02-02 |
30-day Notice |
| S003 |
2012-02-02 |
30-day Notice |
| S002 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S001 |
2012-01-31 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices