Minuteful-kidney test

by Healthy.io  · Based in Israel → — Transforming the smartphone camera into a medical device
Family Medicine Internal Medicine Nephrology
Website
Claim this tool
Is this the maker? Claim the company →

Contact vendor for details
Regulatory Status Disclosed

Overview

The Minuteful Kidney test by Healthy.io is an innovative, smartphone-powered solution designed for the early detection and management of Chronic Kidney Disease (CKD). It transforms an ordinary smartphone camera into a clinical-grade medical device through the integration of computer vision, artificial intelligence, and colorimetric analysis.

The system comprises a home-use kit and a user-friendly mobile application that guides individuals step-by-step through the process of collecting a urine sample, dipping a test strip, and scanning it with their smartphone. The AI and computer vision technology analyze the test strip, calibrating for lighting conditions and device type, to provide immediate, clinical-grade results for albumin and creatinine levels, as well as their ratio (ACR).

These results are securely transmitted to the patient’s healthcare professional for review and follow-up, facilitating early intervention and improved patient care. The Minuteful Kidney test aims to increase adherence to annual ACR testing, particularly among at-risk populations with conditions like diabetes and hypertension, who often miss traditional in-clinic tests.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Smartphone-powered urine analysis
  • AI and computer vision technology for accurate readings
  • Home-use test kit for convenience
  • Semi-quantitative measurement of albumin and creatinine (ACR)
  • Delivers clinical-grade results instantly
  • Step-by-step guidance via mobile app
  • Secure transmission of results to healthcare professionals
  • Proprietary Color-Board for standardized lighting and accuracy
  • Enables early detection of Chronic Kidney Disease (CKD)
  • Proven to increase patient adherence to testing

Use Cases

  • Early detection of Chronic Kidney Disease (CKD)
  • Monitoring kidney health in at-risk populations (e.g., diabetes, hypertension)
  • Improving adherence to annual urine ACR testing
  • Remote patient monitoring for chronic conditions
  • Closing HEDIS gaps for Kidney Health Evaluation (KED) measure
  • Reducing health inequities by increasing access to care

What Physicians Need to Know

LIS/LIMS Integration
Results are securely sent to the doctor/prescribing physician for further care and can be integrated into electronic medical records (EMR) if desired. The system includes a backend server for data management and direct data integration into professional healthcare systems.
Supported Assay Types
The Minuteful-kidney test provides semi-quantitative measurement of albumin and creatinine in urine, and calculates their ratio, the albumin-creatinine ratio (ACR or uACR). It specifically uses YD URiSCAN dipsticks.
QC/QA Features
The system transforms a smartphone camera into a medical-grade diagnostic device using computer vision, AI, and colorimetric analysis. A proprietary Color-Board standardizes lighting conditions and calibrates the dipstick scan for accuracy. The test applies exclusion criteria for extreme pH or diluted samples and is FDA cleared. No user calibration or maintenance is required.
Result Interpretation AI
Advanced computer vision, artificial intelligence, and image recognition algorithms analyze the test strip to detect albumin and creatinine levels and calculate the uACR. The AI calibrates the dipstick scan and analyzes results regardless of lighting conditions or device type, providing immediate clinical-grade results.
Critical Value Alerts
The system categorizes results as Normal (300 mg/g), aligning with KDIGO albuminuria categories. If albuminuria is detected, the user is advised to seek medical follow-up, and the GP will be notified for further action.
Instrument Interfaces
The Minuteful-kidney test leverages a standard smartphone camera as its primary 'instrument interface,' transforming it into a urine analyzer. It consists of a smartphone application, a proprietary Color-Board, and an ACR Reagent Strip.
Reference Range Intelligence
Results are reported with predefined categories (Normal, Abnormal, High abnormal) for ACR, which are consistent with Kidney Disease u2013 Improving Global Outcomes (KDIGO) guidelines. The albumin and creatinine measurements are traceable to international reference materials (CRM 475 from IFCC and SRM 914a from NIST, respectively).
Turnaround Time Impact
The test provides immediate clinical results to the user, with the entire process taking approximately three minutes, including a 75-second reaction time. This eliminates the need for sample transport to a lab and significantly increases testing adherence.
Physician Tip

Physicians should emphasize the convenience and ease of use of the Minuteful-kidney test to patients, as this leads to significantly higher adherence rates for annual ACR testing, particularly in at-risk populations with diabetes or hypertension. It's crucial to stress that while results are immediate, any abnormal findings require prompt clinical follow-up and integration into the patient's comprehensive care plan. The test is prescription-use only, and results should always be interpreted in conjunction with other clinical evaluations to guide patient management and enable early intervention for CKD.

The Minuteful-kidney system is designed for seamless integration with Electronic Medical Records (EMR) and healthcare provider systems. Its backend server and Image Validation Transfer System (IVTS) ensure secure delivery of analyzed test results to clinicians and compatibility across diverse smartphone platforms. This direct data flow facilitates efficient care coordination, follow-up actions, and supports closing care gaps for chronic kidney disease management.

Details

Category Lab & Diagnostics, Wearables & Remote Monitoring (RPM)
Pricing Contact vendor for details
  • Complimentary test kits available through certain programs (e.g., Detect the SOS initiative sponsored by Boehringer Ingelheim); contact vendor for details
DeploymentCloud-based, Mobile App
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The Minuteful Kidney test received 510(k) clearance from the U.S. FDA for home use as an in-vitro diagnostic urine analysis test system for semi-quantitative measurement of albumin and creatinine, and their ratio (ACR), to aid in the assessment of kidney health. The latest clearance K222921 was granted on September 8, 2023.
Integrations
EHR Not specified
Specialties Family Medicine, Internal Medicine, Nephrology

What the Web Says

The Minuteful Kidney test by Healthy.io is an FDA-cleared, prescription-use home urine test that transforms a smartphone into a clinical-grade urine analyzer for early detection of chronic kidney disease (CKD). It measures the albumin-to-creatinine ratio (ACR) and is designed for high-risk populations, such as those with diabetes or hypertension. The test aims to improve adherence to CKD screening by offering a convenient, at-home option with rapid results shared directly with healthcare providers.

Overall: Positive

Strengths

  • High accuracy with 96.4% sensitivity and 98.6% negative predictive value for detecting albuminuria.
  • Convenient and easy to use at home, with step-by-step app guidance and quick results (around 3 minutes).
  • Increases testing adherence, especially among previously untested or hard-to-reach populations.
  • Provides clinical-grade results directly to healthcare providers, facilitating early intervention.
  • Cost-effective compared to usual care, potentially saving healthcare costs.
  • Reduces barriers to care and promotes health equity by leveraging smartphone accessibility.

Limitations

  • Requires access to a smartphone for testing.
  • Some users reported difficulties with the app's scanning process, particularly with lighting, leading to voided tests.
  • Challenges in following up abnormal test results for patients who do not routinely engage with primary care.
  • Limited detailed reports compared to other test kits.
  • Some users experienced communication issues between the company and their GP surgery regarding test legitimacy and results.
  • The app's instructions can be frustrating if not followed precisely, especially regarding timing and starting over.

Based on reviews from: MedGrade Reviews, Apple App Store, Health Technology Wales, Innerbody Research, PR Newswire, Healthy.io, Google Play Store, Diabetes UK Forum, Xtalks, NephU - Minuteful Home Kidney Test Approved In The United States - YouTube, Healthline, Digital Health

Last updated: 2026-07-18

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Minuteful-kidney test

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Xtalks
Healthy.io's Smartphone-Powered Minuteful Kidney Test Gets FDA Clearance
Healthy.io's Minuteful Kidney test received 510(k) clearance from the FDA, becoming the first digital home kidney test to enable early warning of kidney disease. This smartphone-powered test aims to increase adherence to annual ACR testing, which is crucial for early detection but often missed by at-risk individuals.
2022-07
Fierce Biotech
FDA clears Healthy.io's smartphone-based AI test for early-stage kidney disease
The FDA cleared Healthy.io's Minuteful Kidney test, a smartphone-based AI test for early-stage kidney disease, which uses a standard albumin-to-creatinine ratio (ACR) test. The app guides users through the process and analyzes the sample using AI to provide immediate results.
2022-07
PR Newswire
Healthy.io Receives Landmark FDA Clearance For First And Only Smartphone-Powered Home Kidney Test
Healthy.io announced it received 510(k) clearance from the FDA for home use of the Minuteful Kidney test, marking the first time the FDA has granted clearance for a smartphone-powered home test to determine albumin to creatinine ratio (ACR). This clearance allows individuals to conduct a urine test using their smartphone camera to detect early signs of CKD.
2022-07
FirstWord HealthTech
Smartphone-enabled home test accurately detects early signs of chronic kidney disease
A recent study showed Healthy.io's Minuteful Kidney Test accurately identifies markers of chronic kidney disease (CKD), outperforming guideline-recommended methods. The test achieved 96.4% sensitivity and 84.2% specificity, potentially mitigating under-detection of CKD.
2024-11
Healthy.io Blog
Minuteful Kidney Receives FDA Clearance
Healthy.io announced FDA 510(k) clearance for its Minuteful Kidney test, allowing at-home kidney function testing with instant, clinical-grade results via smartphone. This solution aims to address the low adherence rates for annual urine albumin-to-creatinine tests among at-risk individuals.
2022-07
PR Newswire
Healthy.io Named Best Digital Diagnostics Solution for 2023 by Juniper Research for Minuteful Kidney Test
Juniper Research's Future Digital Awards 2023 recognized Healthy.io as the platinum winner for 'Best Digital Diagnostics Solution' for its Minuteful Kidney test. The award highlights the test's innovative approach to enabling early detection of chronic kidney disease at home using a smartphone camera.
2023-04
Journal of Applied Laboratory Medicine
Diagnostic Accuracy of Smartphone-Enabled Urinary Albumin-to-Creatinine Ratio Testing
This study evaluated the diagnostic accuracy of the FDA-cleared Minuteful Kidney Test (MKT) against a standard laboratory method for detecting albuminuria in individuals at risk for CKD. The MKT demonstrated high sensitivity (96.4%) and acceptable specificity (84.2%), exceeding guideline thresholds.
2025-09
Healthy.io
Healthy.io Partners with Blue Cross of Idaho to Increase Access to Kidney Testing
Healthy.io partnered with Blue Cross of Idaho to provide Minuteful Kidney test kits to employees and Medicare Advantage members, aiming to increase access to early detection of kidney damage and chronic kidney disease. This collaboration seeks to improve ACR test completion and kidney health, especially in rural or underserved areas.
2022-12

Videos

Product demos, reviews, and walkthroughs for Minuteful-kidney test.

View all on YouTube

Frequently Asked Questions

The Minuteful Kidney test employs a smartphone application with computer vision and an AI-powered image recognition algorithm to analyze urine dipstick results for albumin and creatinine. For physicians, the workflow involves prescribing the test, with results securely transmitted directly to the prescribing physician for review and integration into the patient's care plan.
The Minuteful Kidney test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a prescription-use, at-home in-vitro diagnostic system. While specific details on data privacy for its AI components aren't fully elaborated in the search results, it is stated to be GDPR compliant in the UK, and results are securely sent to the physician.
Clinical studies have demonstrated high accuracy for the Minuteful Kidney test, showing 96.4% sensitivity and 84.2% to 87.1% specificity for detecting albuminuria, comparable to gold-standard laboratory tests. Limitations include its prescription-only nature, requirement for a compatible smartphone, and that results are intended as an aid in assessment, not a standalone diagnosis, meaning it may not detect every instance of kidney disease.
The Minuteful Kidney test is unique as the first and only FDA-cleared smartphone-powered at-home uACR test, leveraging AI for immediate, clinical-grade results from a urine sample. This contrasts with traditional lab tests requiring clinic visits or other at-home kits that may involve blood samples or lack direct physician integration and FDA clearance for their specific AI interpretation method.
The Minuteful Kidney test is a prescription-use device, and while pricing can vary, it is often provided at no cost to eligible patients through health systems or sponsored programs. Patients, providers, and other third parties are generally not permitted to seek reimbursement for this specific test from health insurers or government programs.
The Minuteful Kidney test is designed for direct data integration into professional healthcare systems, with results automatically and securely sent to the patient's prescribing physician. This facilitates early medical intervention and helps bridge gaps in care by providing a convenient way for at-risk patients to complete guideline-recommended testing.
The Minuteful Kidney test uses a color-board to standardize lighting conditions, minimizing scanning errors and potential biases related to environmental factors. Its at-home nature aims to address health disparities by increasing testing adherence among previously untested populations, including underserved communities, who face barriers to traditional lab testing.

Related Tools

LabLynx AI-Powered LIMS
LabLynx
Lab & Diagnostics
LabLynx AI-Powered LIMS integrates AI and Machine Learning into laboratory information management systems to automate complex analyses, predict outcomes, and optimize workflows for various lab settings. The platform offers LIMS, ELN, and Lab Automation suites, providing configurable and scalable solutions for diverse laboratory needs.
August AI
August AI
Lab & Diagnostics
August AI offers an AI-enabled telehealth platform with an AI health chatbot and virtual care services, including telehealth visits and prescription management. The company's AI chatbot is available globally for free, providing information and not medical advice. In the U.S., August AI offers August Care, a membership that provides clinical services, discounted labs, and quick prescriptions.
$0 (chatbot) / $39 per visit / $39 per month (august care membership)
Allergios®
Allergios®
Lab & Diagnostics
Allergios® is developing an in-vitro diagnostic system that directly visualizes allergic responses in blood serum to provide unambiguous allergy diagnoses, starting with food allergies.
PNOĒ
PNOĒ
Endocrinology & Metabolic AI
PNOĒ is a science-backed cardiometabolic analyzer that performs comprehensive breath-based assessments to measure 23 biomarkers, including VO₂ max, resting metabolic rate (RMR), fat burn efficiency, and biological age. It delivers a 360° snapshot of an individual's physiology by analyzing how oxygen flows through the lungs, heart, and cells. The insights generated are used to personalize nutrition, exercise, and longevity plans.
Varies
Folklore Clinical Variant Interpretation
Helena Bioinformatics
Lab & Diagnostics
Folklore is a clinical variant interpretation platform for genetic laboratories and researchers that brings genomic annotation, ACMG/AMP classification, phenotype and inheritance evidence, literature, and structured reporting into one traceable workflow.
Freemium
Insitro
Insitro
Drug Discovery & Research
Insitro combines automated cellular experiments with population-scale genetics to build Physical AI systems that reveal causal drivers of human disease and deliver targeted therapeutics.

See all Lab & Diagnostics tools →

More from Healthy.io

ACR LAB Urine Analysis Test
Healthy.io
Endocrinology & Metabolic AI
Healthy.io's ACR LAB Urine Analysis Test System uses AI and smartphone technology for semi-quantitative detection of albumin and creatinine in urine, providing clinical-grade results for kidney function assessment at the point of care.
Contact for pricing
DIP/U.S. Urine Analysis Test System
Healthy.io
Lab & Diagnostics
Healthy.io's smartphone-powered AI urine analysis system enables clinical-grade, at-home testing for conditions like kidney disease and UTIs, leveraging computer vision and artificial intelligence.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed Minuteful-kidney test

Funded through the company that built this tool.

eHealth Ventures
VC AI T3
Modi'in Illit, Israel
$250k-$1M
eHealth Ventures is a specialized digital health fund and incubator headquartered in Modi’in Illit, Israel, backed by Maccabi HMO and the Cleveland…
AI/ML in Healthcare Digital Health
Samsung Next
Corporate VC T3
Mountain View, United States
unknown
Samsung Next is the venture and innovation arm of Samsung focused on consumer software, AI, and digital platforms, including selectively digital health,…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
AI Tool Finder
AI-powered search. Results may not be comprehensive.