MICROLET®NEXT 2 Lancing Device

The MICROLET®NEXT 2 Lancing Device is a pen-like instrument used with disposable MICROLET®NEXT lancets to perform controlled skin punctures for obtaining capillary blood samples. It is intended for single-patient use and can be disinfected after each use, providing a 3-year use life.

The device shares the same fundamental technological characteristics and contract manufacturer as the predicate Sterilance Lancing Device. Key differences include: disinfection capability after each use (versus once-weekly for predicate), 3-year use life (versus 5-year predicate), tighter AST penetration depth specification of 2.45±0.55mm (versus 1.1-3.0mm predicate), and different available colors (Gray, Black, White versus Gray, White, Orange predicate).

Not stated in this summary.

Substantial equivalence is supported by identical indications for use, same fundamental technological design and manufacturing, and non-clinical/clinical testing demonstrating the proposed device is as safe and effective as the predicate. A clinical study of 131 subjects with diabetes showed the device could obtain adequate blood volumes and demonstrated no adverse events, with performance equivalent to the predicate Sterilance Lancing Device despite minor design modifications.