Seventh Sense Biosystems Incorporated, a company that has designed and developed TAP, the world's first push-button blood collection device, has announced today that TAP has received United States Food and Drug Administration (FDA) 510(k) approval.
The technology is claimed to represent a landmark innovation in the blood collection industry, where one billion blood draws are performed each year for diagnostic testing.
Blood can be drawn with TAP by placing it on the upper arm and collection starts with a press of a button. The process takes two to three minutes.
The current clearance allows healthcare workers to use TAP to collect capillary blood for haemoglobin A1c (HbA1c) testing, which is routinely used to monitor blood sugar levels in diabetic or pre-diabetic patients. 7SBio is working with the FDA to expand the use of TAP to add additional tests, as well as 'at home' collection.
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