ABBOTT AFP-EIA
FDA premarket approval P820060/S024 · decided 2010-02-26
Approval details
- PMA number
- P820060
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AFP-EIA
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2009-11-20
- Decision date
- 2010-02-26
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- 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
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