LetsGetChecked Impress

The LetsGetChecked ImPress is a single-use blood lancing device designed to produce microliter capillary whole blood samples from the upper arm. It has an integral sharps injury prevention feature with two contact-activated lancets that automatically retract after puncturing the skin. The device does not collect or transport blood samples.

Both the ImPress and predicate device use spring-loaded blade(s) to penetrate skin, a retraction mechanism to safely withdraw the blades, a lock-out feature to prevent re-deployment, manual mechanical activation, medical adhesive to seal the device to skin, and spring force to create vacuum at the incision site for blood emergence.

ASTM F1980 (shelf-life testing), D7386-16 and D4169-22 (transport testing), ISO 10993-5 (biocompatibility/cytotoxicity testing), and usability testing to verify user comprehension and device performance.

The underlying principle of both devices—penetrating capillary blood vessels and applying vacuum to draw out whole blood samples—is identical. Both devices employ the same core technological elements including spring-loaded blades, retraction mechanisms, lock-out features, mechanical activation, and vacuum generation. Non-clinical testing demonstrates the ImPress meets or exceeds the safety, effectiveness, and performance standards of the legally marketed predicate device, establishing technological and functional equivalence.