LetsGetChecked Lancing Device Nabs FDA 510(k) Clearance

Original from: 360dx

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use.

The single-use blood lancing device is intended to produce microliter capillary whole-blood samples and provide an alternative to finger-prick blood draws. It produces a blood volume of up to 600 ul in a point-of-care setting, LetsGetChecked noted in a statement. 

The device applies a vacuum over the lancet site to ensure a more consistent and higher-quality sample and reduce the occurrence of hemolysis, according to the firm's website. It is not intended as a blood collection kit or for at-home collection or collection by a lay user.

"With this revolutionary product, we can elevate the patient experience, ensure more consistent delivery of results, and ultimately, improve health outcomes," LetsGetChecked Chief Operating Officer Ronan Ryan said in a statement.

Source: LetsGetChecked Lancing Device Nabs FDA 510(k) Clearance