Medtech Insight is part 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

Gen-Probe Considers Resubmitting 510(k) After FDA Denies Tigris System

This article was originally published in The Gray Sheet

Executive Summary

Gen-Probe says it will likely re-file a 510(k) for the Procleix Tigris system for use with Chiron's Ultrio assay after the FDA found it "not substantially equivalent" to previously cleared blood screening technology

You may also be interested in...



Gen-Probe blood-screening assay

Firm submits a biologics license application supplement Jan. 29 to run Novartis' Procleix Ultrio blood screening assays for HIV-1 and hepatitis C on its fully automated Tigris system. Ultrio is 510(k)-cleared to screen for those diseases and to detect hepatitis B on the firm's eSAS enhanced semi-automated system. Gen-Probe also plans to begin a postmarket study in March to support an upgrade for Ultrio to screen for hepatitis B on Tigris. FDA originally denied clearance of Ultrio on Tigris in 2005 (1"The Gray Sheet" Oct. 10, 2005, p. 12). Firm also receives a CLIA waiver for its standalone Aptima assay for Chlamydia to test liquid Pap specimens on Tigris...

Gen-Probe blood-screening assay

Firm submits a biologics license application supplement Jan. 29 to run Novartis' Procleix Ultrio blood screening assays for HIV-1 and hepatitis C on its fully automated Tigris system. Ultrio is 510(k)-cleared to screen for those diseases and to detect hepatitis B on the firm's eSAS enhanced semi-automated system. Gen-Probe also plans to begin a postmarket study in March to support an upgrade for Ultrio to screen for hepatitis B on Tigris. FDA originally denied clearance of Ultrio on Tigris in 2005 (1"The Gray Sheet" Oct. 10, 2005, p. 12). Firm also receives a CLIA waiver for its standalone Aptima assay for Chlamydia to test liquid Pap specimens on Tigris...

Quidel’s Stock Soars In Response To Avian Flu Threat, Gains 22.7% In October

Anticipation of the flu season and the threat of a global pandemic fueled Wall Street's attention on influenza test manufacturer Quidel in October

UsernamePublicRestriction

Register

OM013626

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