PMA P820060S024

Device: ABBOTT AFP-EIA
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S024
Product code: LOK
Decision date: 2010-02-26
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
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.

Current openFDA PMA Record

Device: ABBOTT AFP-EIA
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S024
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2010-02-26
Decision code: APPR
Date received: 2009-11-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.