DIP/U.S. Urine Analysis Test System

by Healthy.io  · Based in Israel → — Healthcare at the speed of life
Nephrology Obstetrics & Gynecology Urology

Contact for pricing
Regulatory Status Disclosed

Overview

Healthy.io transforms the smartphone camera into a clinical-grade medical device, leveraging computer vision and artificial intelligence algorithms to enable at-home urine analysis. Their flagship product, Minuteful Kidney (formerly Dip.io), allows users to perform urine tests for conditions like chronic kidney disease (CKD), urinary tract infections (UTIs), and pregnancy complications from the comfort of their homes. The system captures test strip images using a smartphone camera, analyzes the chemical color, and provides instant, clinical-grade reports. This technology aims to democratize access to critical health tests, improve patient adherence to screening, and integrate results seamlessly with healthcare providers’ electronic medical records.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Smartphone-powered urine analysis
  • AI and computer vision for accurate results
  • At-home testing convenience
  • Clinical-grade diagnostic accuracy
  • Instant test results
  • Detection of albumin-to-creatinine ratio (ACR) for kidney health
  • Detection of urinary tract infections (UTIs)
  • Support for prenatal care monitoring
  • Electronic Medical Record (EMR) / Electronic Health Record (EHR) integration
  • Step-by-step in-app guidance for users

Use Cases

  • Early detection and monitoring of Chronic Kidney Disease (CKD)
  • Screening and management of Urinary Tract Infections (UTIs)
  • Monitoring for pregnancy complications
  • Managing patients with diabetes and hypertension at risk of CKD
  • Facilitating remote patient monitoring programs
  • Increasing patient adherence to recommended health screenings

What Physicians Need to Know

LIS/LIMS Integration
The system facilitates seamless integration with Electronic Medical Records (EMRs) such as EMIS and SystmOne, ensuring test results are automatically uploaded to a secure online portal or directly transmitted to the patient's EMR for clinician review.
Supported Assay Types
The 'DIP/U.S. Urine Analysis Test System' (also known as Dip.io or Minuteful 10) supports semi-quantitative detection of up to 10 parameters including glucose, specific gravity, blood, pH, protein, leukocytes, nitrites, ketones, urobilinogen, and bilirubin. It also provides semi-quantitative analysis of microalbumin, creatinine, and the albumin-to-creatinine ratio (ACR). The 'Minuteful Kidney' test specifically focuses on semi-quantitative measurement of albumin and creatinine, and their ratio (ACR), for kidney disease screening.
QC/QA Features
The system employs computer vision algorithms and a unique calibration method to ensure accurate and clinical-grade readings, normalizing analysis regardless of the testing environment, smartphone device, or lighting conditions. No user calibration or maintenance is required. Performance has been validated through extensive laboratory and clinical trials, demonstrating high agreement with commercially marketed urine analyzers.
Result Interpretation AI
Healthy.io's technology leverages AI and machine learning for colorimetric analysis and image recognition algorithms to accurately analyze the urine test strips. This transforms a smartphone camera into a clinical-grade medical device for interpreting results.
Critical Value Alerts
While not explicitly termed 'critical value alerts,' the system securely delivers analyzed test results in real-time directly to the patient's prescribing physician or healthcare provider for review. This enables clinicians to initiate appropriate follow-up care based on the results, particularly for abnormal findings like elevated ACR, which can indicate kidney disease.
Instrument Interfaces
The system utilizes a smartphone application in conjunction with a proprietary Color-Board and specific reagent strips. The smartphone camera acts as the interface, scanning the dipstick against the Color-Board to capture and analyze the test results. The app is compatible with a wide range of Android and iOS smartphones.
Reference Range Intelligence
The system provides semi-quantitative measurements for various urine analytes and their ratios (e.g., ACR). Results are intended to be used in conjunction with clinical evaluation to aid in the assessment of kidney health and guide patient management and care.
Turnaround Time Impact
The system significantly reduces turnaround time, providing clinical-grade results to patients within seconds or minutes of performing the at-home test. These results are then securely and immediately transmitted to the healthcare professional for real-time review and follow-up.
Physician Tip

Healthy.io's smartphone-powered urine analysis systems, such as Minuteful Kidney and Minuteful 10, offer a convenient and clinically validated method for at-home urine testing. Physicians can leverage this technology to improve patient adherence to recommended screenings, particularly for chronic conditions like kidney disease and UTIs. The immediate availability of results and seamless EMR integration can facilitate earlier intervention and more efficient patient management. Encourage at-risk patients, especially those with diabetes or hypertension, to utilize this tool for regular monitoring, as it can significantly enhance early detection and proactive care. Remember that results should always be interpreted in conjunction with the patient's full clinical picture.

Healthy.io's solutions are designed for seamless integration into existing clinical workflows. The system securely transmits patient results directly into Electronic Medical Records (EMRs) like EMIS and SystmOne, eliminating manual data entry and reducing administrative burden. This real-time data flow supports efficient review by healthcare professionals and facilitates timely follow-up actions, enhancing overall care coordination and patient management.

Details

Category Lab & Diagnostics
Pricing Contact for pricing
  • Revenue generated through partnerships and B2B transactions with healthcare systems and providers; products structured around subscription models or service agreements; often provided at zero cost to the patient through health systems
DeploymentCloud-based, accessed via smartphone application
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Healthy.io's urinalysis product (Dip.io) received FDA clearance as a Class II clinical diagnostic device in 2018 (K173327). The Minuteful Kidney test later received 510(k) clearance from the U.S. Food and Drug Administration in July 2022 for home use, allowing people to test their kidney function from home with instant, clinical-grade results across all current iOS and Android devices.

Integrations
EHR Not specified
Specialties Nephrology, Obstetrics & Gynecology, Urology

What the Web Says

The Healthy.io DIP/U.S. Urine Analysis Test System, also known as Dip.io or Minuteful Kidney Test, transforms a smartphone camera into a clinical-grade urinalysis device for at-home use. It has received Class II FDA approval and is designed to make routine urine testing more accessible and convenient for patients, particularly those with chronic conditions like kidney disease, diabetes, and hypertension, as well as pregnant women. Studies have shown high rates of patient satisfaction and ease of use, with many preferring at-home testing over traditional clinic visits.

Overall: Positive

Strengths

  • Convenience and ease of use for at-home testing.
  • FDA-cleared and clinically validated to be equivalent to lab-based testing.
  • Provides quick results, often within minutes.
  • Can improve patient adherence to testing and early detection of conditions like chronic kidney disease.
  • Reduces the need for clinic visits, saving time and potentially healthcare costs.
  • Offers a solution for color-blind patients or caregivers to accurately perform urine dipstick tests.

Limitations

  • Dipstick tests, in general, can have limitations in accuracy, with some studies indicating they may miss a significant percentage of infections or produce false positives/negatives, especially for certain parameters or in specific patient populations.
  • Some dipstick methods, including automated ones, may overestimate certain values like albumin-to-creatinine ratio (ACR), leading to false positives that require confirmation with quantitative methods.
  • The cost per kit can be higher than traditional physical urine dipstick tests, although it may be offset by reduced clinic visit costs.
  • Requires a compatible smartphone and internet access.
  • Limited provider feedback in some studies.
  • Cannot be interpreted manually; requires the smartphone application for data processing.

Based on reviews from: PR Newswire, DPReview, PMC (American Journal of Obstetrics and Gynecology, Children's Hospital of Philadelphia, Journal of Family Medicine and Primary Care, BMC Urology, Kidney International Reports), Urology Times, Minuteful Kidney Test (Healthy.io) Review: Clinical-Grade Renal Monitoring at Home, ICT&health, Urology Times, Reddit, Trustpilot, MDPI, Walmart

Last updated: 2026-07-18

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Press & Coverage

U.S. Food & Drug Administration (FDA)
DIP/U.S. Urine Analysis Test System 510(k) Premarket Notification
This regulatory document details the FDA's 510(k) clearance for the DIP/U.S. Urine Analysis Test System, outlining its intended use for prescription home-use to detect various analytes in urine and aid in diagnosing and monitoring kidney and endocrine disorders.
2018-07
The Open Public Health Journal
The Progress and Future of Artificial Intelligence in Nursing Care: A Review
This review article discusses the integration of AI in nursing care, mentioning the DIP/U.S. Urine Analysis Test System as an AI-based kit with a smartphone application that measures urine parameters and provides results directly to clinicians for kidney disease diagnosis and monitoring.
2024-05
PMC (PubMed Central)
Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance
This article discusses the development of mobile apps for reading rapid diagnostic tests and references the FDA's 510(k) premarket notification for the DIP/U.S. Urine Analysis Test System as an example of a regulatory authorized app.
2020-01
Nuffield Trust
Developing the digital skills of the social care workforce
This report on developing digital skills in the social care workforce mentions the use of a urinalysis dip test linked to a smartphone, referencing the DIP/U.S. Urine Analysis Test System's FDA approval letter.
2021-09
ACS Publications
Engineering Steps for Mobile Point-of-Care Diagnostic Devices | Accounts of Chemical Research
This article discusses the engineering challenges and strategies for developing mobile point-of-care diagnostic devices, citing the FDA's 510(k) Premarket Notification for the DIP/U.S. Urine Analysis Test System.
2019-08
Scribd
Artificial Intelligence and Machine Learning (AIML) - Enabled Medical Devices FDA
This document lists FDA-approved Artificial Intelligence and Machine Learning (AIML) enabled medical devices, including the DIP/U.S. Urine Analysis Test System.
2022-07
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u7f8eu56fdu4ebau5de5u667au80fdu533bu7597u5668u68b0u76d1u7ba1u4e0eu5e94u7528u5206u6790 (Analysis of AI Medical Device Regulation and Application in the US)
This analysis of AI medical device regulation in the US mentions the DIP/U.S. Urine Analysis Test System as an FDA-approved home-use urine test prescription software.
2021-02
HealthAidb
Alternative products to NicoBoard - HealthAidb
This page lists alternative products to NicoBoard, including the DIP/U.S. Urine Analysis Test System by Resonance Health Analysis Services.
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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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