Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

The Disposable Blood Lancet (available in four models: Soft Pro, Softsure, Softsure Pro, and Softsense) is a single-use sterile medical device designed for capillary blood sampling. It consists of a stainless steel needle encapsulated in a plastic needle body with a protective cap that is twisted off to expose the needle. The device is sterilized by radiation to a sterility assurance level of 10^-6.

The subject devices are identical to the predicate in product code (QRK/QRL), regulation, classification, sterilization method, gauges (21G–33G), and materials (stainless steel needle; polyethylene body and cap). The primary difference is needle exposed length: Soft Pro, Softsure, and Softsure Pro have 3.20±0.60 mm, while Softsense has 2.50±0.60 mm, compared to the predicate's uniform 3.20±0.60 mm. Indications for use differ slightly (sampling versus collection), but penetration depth depends on compatible lancing device.

ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) was used for biocompatibility testing, which included cytotoxicity, skin sensitization, intracutaneous reactivity, and acute systemic toxicity.

Substantial equivalence is established because the subject devices share the same intended use (capillary blood sampling), regulatory classification (Class II, 21 CFR 878.4850), and all critical technological characteristics with the predicate. The needle length variation for the Softsense model does not raise safety or effectiveness concerns because penetration depth is ultimately controlled by the compatible lancing device, not the lancet itself. Biocompatibility and bench testing (appearance, dimensions, sharpness, binding strength, compatibility with lancing devices) demonstrate equivalent performance. Therefore, the physical dimension difference—the only substantive variation—does not affect the device's fundamental safety and efficacy profile.