| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
| |
| Trade Name | ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC |
|---|
| Classification Name | test, hepatitis b (b core, be antigen, be antibody, b core igm) |
|---|
| Applicant | ROCHE DIAGNOSTICS CORP. |
|---|
| PMA Number | P100031 |
|---|
| Date Received | 07/30/2010 |
|---|
| Decision Date | 06/22/2011 |
|---|
| Product Code | |
| Docket Number | 11M-0502 |
|---|
| Notice Date | 07/01/2011 |
|---|
| Advisory Committee |
Microbiology |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the elecsys anti-hbc immunoassay & elecsys precicontrol anti-hbc for use on the modular analytics e170 immunoassay analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum and plasma (lithium-heparin, sodium-citrate, k2-edta) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. The detection of total anti-hbc is indicative of a laboratory diagnosis for hbv infection. Further hbv serological marker testing is required to define the specific disease state. The elecsys anti-hbc immunoassay's performance has not been established for the monitoring hbv disease or therapy. The electro- chemiluminescence immunoassay "eclia" is intended for use on the modular analytics ei70 immunoassay analyzer. The elecsys preci-control anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the modular analytics e170 immunoassay analyzer. |
| Approval Order |
Approval Order
|
| Supplements: |
S001 S002 S003 S004 S005 S006
S010 |
|
|
