DIP/U.S. Urine Analysis Test System

The DIP | U.S. Urine Analysis Test System is a prescription home-use device enabling patients to perform urinalysis using a smartphone application, color-board, and reagent strips, with results transmitted directly to their physician. The system utilizes reflectance photometry and cloud-based image recognition algorithms to semi-quantitatively detect glucose, specific gravity, blood, pH, protein, and qualitatively detect nitrite, aiding in the management of kidney and endocrine disorders.

The DIP | U.S. Urine Analysis Test System, developed by Healthy.io, is designed for prescription-only home use, allowing patients to conduct urinalysis tests. The system comprises a smartphone application (initially for LG Nexus 5), a proprietary Color-Board, FDA-cleared Urinalysis Reagent Strips, a urine receptacle, and a user manual. Its purpose is the semi-quantitative detection of glucose, specific gravity, blood, pH, and protein, along with the qualitative detection of nitrite in urine. The methodology involves the patient using the smartphone app to guide the test procedure. The app captures an image of the reagent strip against the Color-Board, which is then analyzed by an image recognition algorithm running on a secure, HIPAA-compliant cloud-based back-end server. Crucially, the clinical results are transmitted directly to the patient's Electronic Medical Records for physician review, and patients do not have access to these results, ensuring professional interpretation for guiding patient management and aiding in the diagnosis and monitoring of metabolic or systemic diseases affecting kidney function and endocrine disorders. Extensive performance testing demonstrated the system's accuracy and reliability. Analytical performance evaluations, following CLSI guidelines, included precision studies (repeatability 99.3% exact match, reproducibility 98.5% exact match), interference testing (comparable to predicate), limit of detection, and linearity (≥89.4% exact match, 100% ±1 color block accuracy). Stability studies confirmed performance up to 14 months. Additional studies verified robustness under various lighting conditions (99.5% exact match) and physical boundary conditions (99.5% exact match). Two method comparison studies against the ACON Mission U500 Urinalysis System, involving lay users in simulated home environments, showed high usability (>99% task completion) and strong agreement. The first study reported overall ±1 color block agreement >99%, with specific exact matches like 99% for nitrites and 85% for protein. The second study showed exact matches of 91.4% for blood and 89.6% for glucose, with no false negatives for these critical analytes. Software validation was conducted according to relevant IEC, IEEE, and FDA guidelines, including cybersecurity measures.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the system's performance vary across different smartphone models and operating systems beyond the initially validated LG Nexus 5 and Android Lollipop 5.0?; What specific measures are in place to ensure patient adherence to the correct testing procedure and sample handling in an unsupervised home-use setting, beyond the app guidance?; What were the specific "similar results" in interference testing compared to the predicate, and are there any known common medications or dietary factors that significantly impact the accuracy for specific analytes?; Given that patients do not see their results, what is the typical turnaround time from test completion by the patient to result availability for the physician, and how are physicians alerted to new results?; What are the failure modes of the image recognition algorithm (e.g., poor lighting not caught by illumination checks, smudged strip), and how does the system handle ambiguous or unreadable strip images?