Diasol, Inc. Warning Letter Details

Summary

Diasol, Inc. manufactured unapproved medical devices consisting of citric acid solutions in 50% and 20% concentrations intended for cleaning, decalcification, and heat disinfection of hemodialysis machines without an approved premarket approval (PMA) application or investigational device exemption (IDE). The company failed to submit the required 510(k) notification before introducing these devices into interstate commerce, violating section 510(k) of the Federal Food, Drug, and Cosmetic Act, and the devices were therefore deemed misbranded. Additionally, the citric acid solutions were considered adulterated under section 501(f)(1)(B) of the Act because they lacked proper premarket clearance, despite the company holding a separate 510(k) clearance for a different citric acid product intended for sorbent regenerated dialysis applications.