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

ALTERNATE MATRIX IVDs SHOULD UNDERGO CLINICAL STUDIES

This article was originally published in The Gray Sheet

Executive Summary

ALTERNATE MATRIX IVDs SHOULD UNDERGO CLINICAL STUDIES to establish that the tests are as effective as traditional tests in detecting disease and drugs of abuse, a majority of panel members suggested at a Sept. 23 joint meeting of the Clinical Chemistry and Toxicology Devices Panel and the Microbiology Devices Panel in Gaithersburg, Maryland. Maintaining that analytical performance data would not be sufficient, panel members recommended that manufacturers demonstrate the clinical efficacy of in vitro diagnostic devices that use sweat, saliva, hair, tears, and other non-traditional matrices.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT002872

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