ACR LAB Urine Analysis Test

by Healthy.io  · Based in Israel → — If you can text, you can test.
Family Medicine Internal Medicine Nephrology
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Regulatory Status Disclosed

Overview

Healthy.io’s ACR LAB Urine Analysis Test System is an AI-powered in-vitro diagnostic tool designed for use by healthcare professionals in a point-of-care setting. It utilizes a smartphone application, a proprietary Color-Board, and ACR Reagent Strips for the semi-quantitative detection of albumin and creatinine in urine, and the presentation of their ratio (ACR). This system aids in the diagnosis and assessment of kidney function. The technology transforms a smartphone camera into a clinical-grade medical device, providing results equivalent to traditional lab testing. Healthy.io also offers a related home-use version, Minuteful Kidney, which allows patients to perform ACR tests at home, guided by a smartphone app, with results securely shared with their clinicians.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Smartphone-powered urine analysis
  • Semi-quantitative detection of albumin and creatinine
  • Calculates albumin-to-creatinine ratio (ACR)
  • Clinical-grade accuracy equivalent to lab testing
  • Guided testing process via mobile app (video, audio, text)
  • Secure sharing of results with clinicians/EMR integration
  • Proprietary Color-Board and reagent strips
  • AI and machine learning for colorimetric analysis
  • Remote diagnostics/at-home testing capability (Minuteful Kidney)

Use Cases

  • Early detection and monitoring of Chronic Kidney Disease (CKD)
  • Screening for kidney disease in patients with diabetes and hypertension
  • Improving adherence to annual ACR testing
  • Point-of-care testing by healthcare professionals
  • Remote patient monitoring

What Physicians Need to Know

Key Capabilities
Smartphone-based diagnostic test for home use, enabling semi-quantitative detection of albumin and creatinine, and qualitative measurement of their ratio (ACR). The system uses a test kit and a mobile application with AI-powered image recognition software to turn a smartphone into an ACR urine strip analyzer.
Clinical Utility
Aids in early identification of possible kidney disease and guides patient management, particularly for individuals with diabetes, hypertension, or other CKD risk factors. It significantly improves adherence to recommended ACR testing (e.g., from 0% to 73% in one study) and helps detect previously unknown albuminuria.
Integration Options
Results are automatically and securely sent to the referring clinician through Electronic Medical Records (EMR) systems like EMIS and SystmOne. It also integrates with a secure online portal for healthcare professionals and is SMART on FHIR compatible.
Compliance Status
FDA cleared (K210069, K222921) for clinical-grade diagnostic use in the US, CE marked for Europe, and compliant with GDPR and HIPAA. Healthy.io maintains a Quality Management System (QMS) aligned with FDA 21 CFR 820 and ISO 13485:2016, and is ISO/IEC 27001:2013 and HITRUST certified.
Pricing Model
Primarily targets healthcare providers and health plans, offering revenue models that include direct sales of diagnostic kits, usage-based fees (per test processed), subscription models for platform access, and bundled service agreements. A 'pay per protein' model links payment to tangible cost improvements from detecting elevated protein. Kits are often provided at no cost to the patient through health systems.
User Experience
Designed for ease of use with a smartphone app that provides step-by-step guidance via video, audio, and text. High patient satisfaction is reported, with studies showing 94-100% of users finding the test easy to complete and a majority preferring home testing over clinic visits.
Support Quality
Healthy.io provides a patient onboarding team for information and app download support, along with a call center help team for assistance during self-testing. The company emphasizes robust security and data protection with a dedicated in-house security team.
Implementation Complexity
Described as quick and easy to implement for practices, with setup potentially taking under an hour. Healthy.io manages the entire service flow, from shipping test kits to patients' homes to real-time result sharing with clinical teams.
Evidence Base
Supported by clinical studies demonstrating a 2.5-fold increase in uACR test completion rates and high diagnostic accuracy (96.4% sensitivity, 98.6% NPV for albuminuria). NICE concluded that the technology improves compliance and patient preference for home testing.
Physician Tip

Consider integrating the Healthy.io ACR LAB Urine Analysis Test for at-risk patients, especially those with diabetes or hypertension, to improve adherence to annual kidney health screening. The home-based nature and user-friendly app can significantly increase testing rates and facilitate earlier detection of CKD. Leverage the direct EMR integration for seamless result review and timely follow-up, potentially reducing clinic workload and enhancing patient engagement in their care. Be mindful that patients need a smartphone and basic digital literacy to use the service effectively. While highly accurate for detection, always use results in conjunction with comprehensive clinical evaluation.

The Healthy.io ACR testing system is designed for seamless integration with major EMR providers like EMIS and SystmOne, ensuring that test results are automatically uploaded to patient records and accessible via a secure online portal. The platform is also SMART on FHIR compatible, facilitating broader interoperability within healthcare systems. This robust integration capability streamlines clinical workflows and supports real-time patient management.

Details

Category Endocrinology & Metabolic AI, Lab & Diagnostics
Pricing Contact for pricing
  • Healthy.io operates on a B2B model, with services often provided at no direct cost to the patient through health systems
  • A 'pay per protein' model has been mentioned
DeploymentMobile application (iOS and Android) with integration into Electronic Medical Records (EMR) systems like EMIS and SystmOne.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The ACR | LAB Urine Analysis Test System received FDA 510(k) clearance (K182384) on July 26, 2019. It is intended for in-vitro diagnostic use by a healthcare professional in a point-of-care setting for semi-quantitative detection of albumin and creatinine in urine and their ratio, as an aid in the diagnosis for kidney function.
Integrations
EHR Not specified
Specialties Family Medicine, Internal Medicine, Nephrology

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Press & Coverage

FDA
510(k) Premarket Notification - ACR LAB Urine Analysis Test System
This document is a 510(k) Premarket Notification from the FDA for Healthy.io, Ltd.'s ACR LAB Urine Analysis Test System, indicating regulatory clearance for the device. It details the applicant, contact information, regulation number, and classification product code.
2026-05
ARC GM
Rapid Evidence Synthesis: Healthy.io - ARC GM
This rapid evidence synthesis discusses Healthy.io's ACR LAB Urine Analysis Test System, noting its substantial equivalence to standard semiquantitative testing based on FDA regulatory approval. It also highlights NICE's conclusions regarding improved compliance with ACR testing and patient preference for home testing, while identifying uncertainties around long-term follow-up data and accessibility.
unknown
CenterWatch
ACR | LAB Urine Analysis Test System Evaluation of Performance | Clinical Research Trial Listing
This listing describes a completed clinical trial for the ACR LAB Urine Analysis Test System, sponsored by Healthy.io Ltd. The study aimed to evaluate the performance of the prescription-only in vitro diagnostic device for qualitative and semi-quantitative detection of Albumin, Creatinine, and the Albumin-to-Creatinine Ratio.
2020-07
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, referencing the ACR LAB urine analysis test system as an example of an AI-based program with a 510(k) premarket notification in 2023. It highlights the potential of AI to enhance healthcare by improving diagnostics, reducing errors, and enabling remote care.
2024-05
Healthy.io
Healthy.io - Physician Ai Tools
This page from Healthy.io's website mentions their ACR LAB Urine Analysis Test System and provides access to news, demos, and interviews about their technology. It serves as a resource for physicians interested in AI tools for healthcare.
2026-04

Videos

Product demos, reviews, and walkthroughs for ACR LAB Urine Analysis Test.

View all on YouTube

Frequently Asked Questions

The ACR LAB Urine Analysis Test utilizes an image recognition algorithm, often integrated into a smartphone application, to perform qualitative and semi-quantitative detection of albumin, creatinine, and the albumin-to-creatinine ratio (ACR). This AI-driven approach automates the interpretation of urine test strips, aiming to reduce human error and improve efficiency in identifying early kidney damage.
AI in healthcare, including diagnostic tools like the ACR LAB test, is subject to regulations such as HIPAA for data handling and state-specific AI laws. Organizations implementing AI must balance innovation with validated evidence, regulatory compliance, and patient trust, often requiring documented AI policies covering data privacy and vendor evaluation.
Traditional manual microscopy and automated analyzers are established alternatives for urine analysis. While AI-driven solutions like the ACR LAB test offer advantages in sensitivity and quantification for routine screenings, traditional methods may still be preferred for complex cases. Other AI tools are also emerging, with varying levels of accuracy and validation.
The cost of urine analysis tests, including ACR, can vary significantly by location and laboratory type, with basic urinalysis prices ranging from approximately $10 to $28. While specific pricing for the 'ACR LAB Urine Analysis Test' is not detailed, AI-driven home tests can enhance cost-effectiveness by improving adherence to testing guidelines and potentially reducing the need for repeat or unnecessary tests.
Limitations of ACR tests, which AI systems interpret, include potential for temporary elevations due to factors like vigorous exercise, fever, or urinary tract infections, and inaccuracies stemming from improper sample collection or timing variations. Urine concentration effects can also lead to overestimation in dilute samples or underestimation in concentrated ones, and false-positive rates may increase with patient age.
Physician oversight remains crucial for final interpretation and clinical correlation, as AI systems primarily function as decision-support tools that augment professional judgment rather than replace it. It is essential that AI-generated insights are integrated with a comprehensive understanding of the patient's overall clinical picture, and human evaluation is necessary to ensure appropriate care.
While specific update frequencies for the 'ACR LAB' are not explicitly stated, AI models in clinical laboratories generally undergo periodic updates and retraining to incorporate new data and improve performance. These updates require rigorous validation against diverse datasets and clinical benchmarks to ensure continued accuracy and reliability, often involving local acceptance testing, governance, and continuous monitoring.

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Contact vendor for details

View company profile →

Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed ACR LAB Urine Analysis 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
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