In Brief: Base Ten's Prenval I
This article was originally published in The Gray Sheet
Executive Summary
Base Ten's Prenval I: Alpha-fetoprotein software program gains 510(k) clearance from FDA. The program assists in the detection of open neural tube defects by calculating a multiple of the median, managing a database, and generating reports from quantitative measurement of AFP. Base Ten originally filed for approval of the Prenval I via premarket approval application. At a meeting in March, FDA's Immunology Devices Panel voted five to three against approval for the program as a Class III device, concluding that it would be inappropriate to give FDA's approval endorsement to specific weight adjustment formulas included in the system ("The Gray Sheet" April 10, p. 19)