Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD P.O. BOX 50416 INDIANAPOLIS, IN 46250-0457 |
PMA Number | P110031 |
Date Received | 07/29/2011 |
Decision Date | 01/03/2012 |
Product Code |
LOM |
Docket Number | 12M-0024 |
Notice Date | 01/10/2012 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM FOR USE ON THE COBAS E 411 IMMUNOASSAY ANALYZER. THE DEVICE IS INDICATED FOR: ELECSYS ANTI-HBC IGM IMMUNOASSAY, THE ELECSYS ANTI-HBC IGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF IGM 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 CLINICAL INFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC IGM IMMUNOASSAYS 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 411 IMMUOASSAY ANALYZER.ELECSYS PRECICONTROL ANTI-HBC IGM - THE ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR THE QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 411 IMMUNOASSAY ANALYZER. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S008 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 |
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