Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT004739

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel