www.fdanews.com/articles/173673-biophor-diagnostics-receives-510k-clearance-for-seventh-oral-fluid-screening-assay
Biophor Diagnostics Receives 510(k) Clearance for Seventh Oral Fluid Screening Assay
October 20, 2015
Redwood City, Calif.-based Biophor Diagnostics has received FDA 510(k) clearance for its seventh oral fluid screening assay based on the RapidFRET IVD Platform technology.
The most recently cleared assay is for d-methamphetamine at a 50 ng/mL cutoff.
The platform is an oral fluid screening solution featuring a proprietary collection device, homogeneous reagents and an instrument with full walk-away automation.
Biophor develops immunoassays for undiluted oral fluid specimens obtained with its oral fluid collector. — Michael Cipriano