FDAnews
www.fdanews.com/articles/172955-fda-oks-genital-swab-claim-on-focus-diagnostics-simplexa-system

FDA OKs Genital Swab Claim on Focus Diagnostics’ Simplexa System

September 4, 2015

The FDA has granted Focus Diagnostics 510(k) clearance to add the genital swab claim to its Simplexa HSV 1 & 2 Direct molecular test on the integrated cycler.

The new labeling clearance follows de novo 510(k) clearance and CLIA moderate complexity categorization of the test in March 2014 for use with cerebrospinal fluid from patients suspected of HSV central nervous system infection, including encephalitis.

According to Michelle Tabb, vice president of research and development, the added genital swab claim broadens the test's potential clinical utility as an aid in diagnosing infection with one or both herpes simplex viruses. — Michael Cipriano