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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDIASORIN
1951 NORTHWESTERN AVENUE
PO BOX 285
STILLWATER, MN 55082-0285
PMA NumberP890019
Supplement NumberS005
Date Received11/24/1997
Decision Date09/22/1998
Reclassified Date 02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in the Enzyme tracer and Tracer Diluent from an IgG (Human) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control and Negative Control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-AB-HAVK PLUS and is intended for the qualitative determination of total antiboides to hepatitis A virus (anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the dignosis of current or previous hepatitis A virus infection and as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the identification of HAV-susceptible individuals for vaccination.
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