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Selux Positive Blood Culture Separator Receives FDA 510(k) Clearance

NEW YORK – Selux Diagnostics said this week that the US Food and Drug Administration has given 510(k) clearance to the company's Positive Blood Culture Separator.

The clearance expands the sample types that can be used on the firm's Selux NGP System antimicrobial susceptibility testing platform, Boston-based Selux said, adding that labs can use the Selux PBC Separator, which previously received FDA breakthrough designation, to test directly from positive blood culture without having to subculture the sample as it automatically prepares it for susceptibility testing. The FDA clearance is for the determination of a bacteria's susceptibility to 17 specific antibiotic agents on the Selux Gram Negative Panel, it noted.

Selux previously received 510(k) clearance for a Gram-negative antimicrobial susceptibility panel and for the NGP System.