| 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 | ABBOTT AFP-EIA |
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| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
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| Applicant | Abbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064 |
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| PMA Number | P820060 |
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| Supplement Number | S024 |
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| Date Received | 11/20/2009 |
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| Decision Date | 02/26/2010 |
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| Withdrawal Date | 11/15/2013 |
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| Product Code |
LOK |
| Advisory Committee |
Immunology |
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| Supplement Type | Real-Time Process |
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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 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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