Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

The Medblue Skin Prick Test Applicator is a sterile, single-use, disposable device with multiple test heads (1, 8, 10, or 12) used to administer diagnostic allergenic extracts percutaneously onto the skin surface for allergy testing. The applicator features acrylic or metal tips with protruding tines that utilize capillary action to deliver allergen and leave visible skin indentations without piercing through the epidermis.

The subject device is comparable to the predicate in product code (SCL), indications for use, acrylic polymer construction, sterilization method (ethylene oxide), and shelf life (3 years). Differences include slightly smaller prick size (1.10–1.5 mm vs. 1.2–1.6 mm), larger lancet intervals (20.0–30.5 mm vs. 2.0–2.5 cm), and packaging materials (PET plastic with Tyvek paper versus PET plastic alone).

ISO 10993-1:2018 (biocompatibility evaluation), ISO 10993-5:2009 (cytotoxicity), ISO 10993-7:2008/Amd 1:2019 (ethylene oxide residuals), ISO 10993-10:2010 (skin irritation and sensitization), ISO 10993-11:2017 (systemic toxicity), ISO 11135-1:2014 (ethylene oxide sterilization), ISO 11737-1:2018/AMD 1:2021 and ISO 11737-2:2019 (microbiological sterilization methods).

The subject device raises no new or different questions of safety or effectiveness compared to the predicate because it shares the same intended use, regulatory classification, and core technological design despite minor dimensional and packaging differences. Clinical testing showed no statistically significant differences in allergen delivery effectiveness or pain assessment between the two devices, and biocompatibility and sterilization testing confirmed safety and performance.