Tasso’s Lancet Product Receives 510(k) Class II Medical Device Clearance

Tasso’s Tasso+ lancet has received 510(k) clearance from the FDA as a Class II medical device, becoming the first single-use blood collection product to receive Class II clearance from the FDA as part of the new reclassification process for lancets.

The self-collection device, said the company, offers patients an experience to obtain blood droplets for testing that’s “simple and virtually painless.”

Tasso said that with the agency conducting reclassification of lancet items, it hopes to expand the reach of its device to more pharmaceutical companies, healthcare organizations and academic institutions across the country.

Class II medical devices are considered to have a moderate to high risk to the patient and/or user. Forty-three percent of medical devices fall under this category.