Sandstone Diagnostics’ Trak Volume Cup Cleared by FDA

The FDA gave 510(k) clearance for Sandstone Diagnostics’ Trak volume cup, a new addition to its Trak male fertility testing system.

The volume cup allows patients to measure their semen volume and diagnose hypospermia.

The cup is coated with a liquefaction enzyme that breaks down sample viscosity and allows the user to funnel the sample into a graduate measurement compartment for a simple and accurate reading of semen volume.