Tigris not 'equivalent' for blood assay

Gen-Probe (GPRO) said FDA did not grant 510(k) clearance to the Procleix Ultrio assay for use on the Procleix Tigris system because it is "not substantially equivalent" to screening blood with the assay on the Procleix enhanced semi-automated system (eSAS). The assay has 510(k) clearance for use on eSAS. ...