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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP110025
Date Received06/23/2011
Decision Date12/14/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0917
Notice Date 12/21/2011
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 igm immunoassay and elecsys precicontrol anti-hbc igm for use on the modular anal ytics e170 immunoassay analyzer. This device is indicated for: 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 immunoassay's performance has not been established for the monitoring of hbv disease or therapy. The ectrochemiluminescence immunoassay "eclia" is intended for use on the modular anal ytics e170 immunoassay analyzer. Elecsys precicontrol anti-hbc igm is used for quality control of the elecsys anti-hbc igm immunoassay on the modular anal ytics e170 immunoassay analyzer.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S010 
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