Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use blood lancets designed to puncture a fingertip for capillary blood sampling, primarily for glucose monitoring in diabetic patients. Both devices are sterilized to a sterility assurance level (SAL) of 10⁻⁶ and have a 3-year shelf life.

The Auto Lancet features a spring-loaded mechanism with needle retraction after use and is available in gauges 26G, 28G, and 30G with 1.5 mm needle length. The Lancet Plus is a manual lancet with adjustable-depth lancing device compatibility, available in gauges 26G, 28G, and 30G with 3.0 mm needle length. Both use stainless steel needles, are sterilized by electron beam (versus predicate's gamma), and have minor shape differences from the predicate but employ the same materials and operational principles.

ISO 11137-1:2006/AMD 2:2018, ISO 11137-2:2013/AMD 1:2022, and ISO 11137-3:2017 for sterilization validation; ASTM F1980-21 for shelf-life testing; ISO 10993-1:2019 for biocompatibility; FDA Guidance on Medical Devices with Sharps Injury Prevention Features (August 30, 2024); and 21 CFR 878.4850 special controls for blood lancets.

The subject devices share the same intended use (capillary blood sampling), regulatory classification (Class II, 21 CFR 878.4850), patient population (all ages), and operational principle (single-use lancets with sharps injury prevention) as the predicate VeriFine Safety Lancet. Although needle gauges and lengths differ slightly, they fall within the predicate device's established ranges. Non-clinical performance testing confirmed both devices meet all safety and effectiveness requirements, and the minor shape and sterilization method differences do not introduce new safety or effectiveness concerns, thus establishing substantial equivalence.