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
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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...
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