| 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. |
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| Device | AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS |
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| Generic Name | Hepatitis a test (antibody and igm antibody) |
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| Regulation Number | 866.3310 |
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| Applicant | Diasorin
1951 Northwestern Ave.
P.O. Box 285
Stillwater, MN 55082 |
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| PMA Number | P890019 |
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| Supplement Number | S005 |
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| Date Received | 11/24/1997 |
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| Decision Date | 09/22/1998 |
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| Reclassified Date | 02/09/2006 |
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| Product Code |
LOL |
| Advisory Committee |
Microbiology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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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