The U.S. Food and Drug Administration (FDA) has informed an India-based company that it is expected to file a premarket notification as to its uChek Urine analyzer, software currently for sale on Apple Inc.’s App Store for the screening of diabetes and urinary tract infections. In its May 21, 2013, letter, FDA notes that while the application (app) refers to urinalysis dipsticks that have been cleared for use, “they are only cleared when interpreted by direct visual reading. Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole function[] as an automated strip reader,” thus making the app a medical device under the Food, Drug, and Cosmetic Act, according to FDA.