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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameABBOTT AFP-EIA
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp-eia diagnostic kit
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS024
Date Received11/23/2009
Decision Date02/26/2010
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in software that affected patient results reporting following automated dilution. The low concentration limit flag for the 1:101 automated dilution protocol within the axsym afp assay file was changed from 0 ng/ml on axsym cancer assay disk version 6, ln 3d50-06. The change in question mandates that patient results are flagged, following auto-dilution, when the calculated values of the undiluted sample fall below 40. 40 ng/ml and the measured value of the diluted sample falls below 0. 40 ng/ml.
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