Biophor Diagnostics Receives 510(k) Clearance for Seventh Oral Fluid Screening Assay

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