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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 NumberP100001
Date Received01/29/2010
Decision Date07/20/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0563
Notice Date 08/01/2011
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 vitros immunodiagnostic products anti-hbe reagent pack, calibrator and controls. This device is indicated for: vitros immunodiagnostic products anti-hbe reagent pack for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from hbv infection, using the vitros eci/eciq immunodiagnostic systems. Further assessment of hbv infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. Vitros anti-hbe test performance has not been established for the monitoring of hbv disease or therapy. Vitros immunodiagnostic products anti-hbe calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems when used with the vitros anti-hbe test for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe). Vitros immunodiagnostic products anti-hbe controls for use in monitoring the performance of the vitros anti-hbe test when used on the vitros eci/eciq immunodiagnostic systems.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008