Sandstone Diagnostics Inc. a medical technology startup has recently received US Food and Drug Administration (FDA) 510 (K) clearance for their Male Fertility Testing System: Trak.
510 (K) is a pre-market notification which is required to be made with FDA when a manufacturer plans to market a medical device at least 90 days prior to launch. During this period FDA determines whether the device is safe and effective to use. Before marketing of product manufacturer must receive “Substantially Equivalent or SE” letter from FDA. This basically gives clearance to manufacturer and launch their device in commercial market.
As per recent studies, it is clear that Men contribute to nearly 50% of infertility cases. In order to address this issue, Sandstone Diagnostics developed a device called Trak.
TRAK: It is a Male Fertility System with the definitive data-driven tool to measure, monitor, and improve men’s reproductive health from the comfort and privacy of home.
So, how does it work?
Step 1: Add few drops of sample to the Trak disposable test prop.
Step 2: Load it in the Trak Engine.
Step 3: Start the engine and the engine will spin generating centrifugal force which will then isolate and quantify sperm.
Step 4: Once, the engine completes its task the result will appear in Trak Prop giving you the reading. Higher the white column more the number of sperm.
Trak also has App on Google Play and Apple App Store, which is available for free download. The App basis the results can guide its user with the feedback and understanding of the test results.
Trak Kit includes:
- 4 Disposable Tests
- Testing accessories
- Owner’s Guide
- The Don’t Cook your Balls Guide to Men’s Reproductive Health
Trak kit will start shipping from October’16 and is priced at US $159.99.
Greg Sommer: Co-Founder and CEO
Ulrich Schaff: Co-Founder and CTO
Sara Naab: Co-Founder, Marketing and Quality Director
They have won several awards with latest one “Swimming with the Sharks” 2016 venture competition at Molecular Med Tri-Con.