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Tasso Blood Collection Product Gets FDA 510(k) Clearance

NEW YORK – Tasso announced on Wednesday that its Tasso+ blood collection device has received 510(k) clearance from the US Food and Drug Administration as a Class II medical device.

The device received Class II clearance under the FDA's new reclassification process for lancets as devices that are intended to puncture the skin to get drops of capillary blood samples, the firm said in a statement. The reclassification of lancets from Class I to Class II devices occurred last November.

The clearance will allow Seattle-based Tasso to market and sell the lancet to more pharmaceutical companies, healthcare organizations, and academic institutions, it said.

The single-use device allows for self-collection of a capillary blood sample and can be used with multiple compatible collection tubes, the company noted. The device will be available to customers across the US in the fourth quarter of this year. 

"This FDA Class II medical device clearance will help improve patient care by relieving traditional phlebotomy-related bottlenecks and enabling more individuals to get the tests they need at the time they are needed," Tasso CEO and Cofounder Ben Casavant said in a statement. "We are excited to unlock a new wave of large commercial opportunities for the company and to lead the industry into the future of remote testing."