S-Human Healthcare UR

A Class II IVD medical device (Korea, No. 25-4212) combining a urinalysis strip with AI-based smartphone reading. Place the strip on the color-reference board, capture it with the app, and AI automatically reads 10 clinical parameters: protein, glucose, occult blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes, specific gravity, and pH. Each test takes 60-90 seconds, and results are stored in the app with trend graphs from the last five tests up to one year, with family and group management support. No dedicated hardware is required - only the strip and the app - keeping adoption costs low. A web portal enables institution-level test history management for healthcare professionals. Authorization performance testing confirmed agreement of 90% or higher with a reference analyzer across all parameters. Suitable for home self-testing as well as pharmacy, health screening, and senior-care channels.