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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
PMA NumberP990012
Date Received03/04/1999
Decision Date06/01/2001
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 01M-0507
Notice Date 11/14/2001
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. Hbsag immunoassay, elecsys hbsag confirmatory, and precicontrol hbsag. The devices are indicated for: elecsys hbsag immunoassay is an immunoassay for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (heparin, edta-k3, sodium citrate). Assay results in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. The electrochemiluminescence immunoassay "eclia" is intended for use on the roche elecsys 2010 immunoassay system. Elecsys hbsag confirmatory is an immunoassay for the in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (heparin, edta-k3, sodium citrate) samples repeatedly reactive when tested with elecsys 2010 hbsag immunoassay. Precicontrol hbsag is used for quality control of the elecsys hbsag immunoassay on the elecsys 2010 immunoassay system when testing human serum. The performance of the precicontrol hbsag has not been established with any other hbsag assay.
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S016 S017 S018 S019 S020 
S021 S022