droplet® personal lancets

droplet® personal lancets are sterile, single-use medical devices consisting of a steel needle inside a plastic body with a protective cap. They are intended for use with a lancing device by lay users to obtain capillary blood samples for testing, suitable for children to adults.

The subject device has 28G and 30G needle diameters (available in pink, blue, and violet colors), compared to the predicate's range of 21G–33G. Both use identical sterilization (irradiation, SAL=10⁻⁶), shelf life (5 years), materials (stainless steel needle, polyethylene body/cap), single-use durability, and biocompatibility standard (ISO 10993-1).

ISO 10993-1 (biocompatibility); sterilization per radiation SAL=10⁻⁶; transport testing to simulate packaging/shipping hazards; quality control testing for needle sharpness, orientation, and length.

The device is SE because its needle diameters (28G, 30G) fall within the predicate's established range, and all material composition, sterilization method, shelf life, biocompatibility standard, and intended use are identical. Compatibility testing with commercial lancing devices demonstrates functional equivalence. No new safety or effectiveness issues are raised relative to the predicate.