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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.
1951 northwestern ave.
stillwater, MN 55082-0285
PMA NumberP990044
Date Received07/02/1999
Decision Date03/30/2001
Docket Number 01M-0455
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the diasorin eti-core-igmk plus assay. The device is indicated for: eti-core-igmk plus is an in vitro enzyme immunoassay(eia) intended for use in the qualitative determination of igm antibody to hepatitis b core antigen (igm anti-hbc) in human serum or plasma (edta, citrate or heparin). The eti-core-igmk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The presence of igm anti-hbc, in the presence of total antibody to hbc (anti-hbc) is indicative of a laboratory diagnosis for acute infection. The absence of igm anti-hbc, in the presence of total anti-hbc, is indicative of a laboratory diagnosis for recovery from hbv infection. Further hbv serological marker testing is required to define the specific disease state. The eti-core-igmk plus assay's performance has not been established for the monitoring of hbv disease or therapy. This assay has not been fda-approved for the screening of blood or plasma donors.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S014 S015 S016 S017 S018