TAP Micro Select has received 510(k) Medical Device clearance from the FDA for producing capillary whole blood samples.
YourBio Health Inc, the developers of the world’s first virtually painless push-button blood collection device, announced today that TAP Micro Select received 510(k) Medical Device clearance from the US Food and Drug Administration (FDA). Touch activated phlebotomy (TAP) was developed over the last 15 years to deliver on the goal of developing both painless and remote blood collection.
YourBio Health received FDA clearance in 2019 for the first bladeless lay-person-use device for microcapillary blood diagnostic testing using TAP technology. Adding to the existing CE-marked TAP II device, and TAP Micro, TAP Micro Select uses the same bladeless, high-volume liquid blood collection technology. As measured by independent labs’ usability studies, this technology is significantly preferred by end-users to venipuncture, fingerstick, and competitive devices.
TAP Micro Select is ideally suited for use in decentralized clinical trials and health and wellness testing by reducing barriers to blood collection. Using HALO technology, a bladeless microneedle array, TAP Micro Select delivers virtually painless, large volume collection of up to 500uL of whole, capillary high-quality blood.
“YourBio Health is advancing virtually painless blood collection technologies to meet the growing demand in various blood sampling markets,” says Harry Wilcox, chairman and CEO of YourBio Health and partner, Flagship Pioneering. “Independent research using TAP technologies has demonstrated venous concordance for patient-centric collection meeting the desires of both patients and clinicians; this includes promoting greater diversity in clinical trials and supporting the momentum behind the mega-trend of people wanting to understand and have more control of their health.”