HAI Solutions has earned U.S. Food and Drug Administration (FDA) De Novo classification for its QIKCAP System. The regulatory achievement marks the first and only FDA-granted ultraviolet (UV) light-based microbial reduction device for luer-activated valves, establishing a new Class II medical device category.

The QIKCAP System, comprising the QIKCAP Device and single-use QIKCAP Cap, is engineered to supplement manual disinfection protocols for needle-free luer connectors in intravascular applications. The QIKCAP Device delivers powerful, targeted UV irradiation to the connector septum, resulting in rapid, 10-second microbial reduction. The QIKCAP Cap further provides a protective physical barrier, shielding the connector from environmental contamination for up to seven days if not in use.

HAI Solutions claims the De Novo classification positions the company as a leader in UV microbial reduction medical devices, bolstered by a growing portfolio that includes a strategic partnership with Intellego Technologies for a chromatic dosimeter formulated specifically for UV applications. HAI Solutions supports FDA regulation of UV healthcare devices.

“This De Novo Grant is a huge accomplishment for the HAI Solutions team,” HAI Solutions CEO Nick Perrenoud said. “We are proud to bring this technology to market, addressing a critical need in IV connector maintenance and protection.”

HAI Solutions worked closely with the FDA throughout the De Novo process, adhering to general and special controls that required extensive performance testing under worst-case conditions. These measures ensure the device’s reliability and safety in clinical settings. Under the conditions of testing, the combined use of an 3.15% CHG/70% IPA wipes applied for five seconds and the QIKCAP Device resulted in four-log reductions in Staphylococcus aureus, Klebsiella pneumoniae, Staphylococcus epidermidis, and Enterobacter cloacae. The device has not shown a significant reduction in fungal organisms. A correlation to clinical infection-related outcomes has not been established.

Based in Carlsbad, Calif., HAI Solutions is pioneering cutting-edge intravenous therapy solutions designed to combat IV contamination in challenging hospital environments such as operating rooms, intensive care units, and emergency departments.