FDA Clears Device That Touts “Fast and Virtually Painless” Blood Draw

The FDA granted 510(k) clearance to TAP, a blood collection device that is placed on the upper arm and collects 100 µL of capillary blood with the press of a button, lasting two to three minutes. Seventh Sense Biosystems, Inc., the manufacturer of TAP, claims that the device is “fast and virtually painless.”

The single-use device is attached to the upper arm through vacuum pressure and draws blood through an array of fine needles. The drawn blood is held internally within the device until laboratory analysis of hemoglobin A1c levels. The device uses lithium heparin as its anticoagulant, which the manufacturers noted may limit the range of potential diagnostic testing. They hope to expand the use of TAP to include additional blood tests and at-home collection.

Source: Seventh Sense Biosystems, Inc., press release, February 23, 2017.