Minuteful Kidney Test (Healthy.io)
Strong Clinical Evidence
FDA 510(k) Cleared
Urinalysis Tests

Minuteful Kidney Test (Healthy.io)

by Healthy.io Model: Minuteful Kidney

94/100
Clinical Score
HSA/FSA: Usually Eligible

Key Features

Clinical-grade ACR testing using a smartphone camera and calibration board
Prescription-based model integrated directly with healthcare providers
Validated in clinical trials with high sensitivity for detecting albuminuria
Aids in the early identification of chronic kidney disease

Device Overview

The Minuteful Kidney test is a prescription-use diagnostic system that utilizes smartphone computer vision to analyze urine reagent strips. It measures albumin and creatinine levels to calculate the ACR, providing an early warning system for chronic kidney disease (CKD) in high-risk populations such as those with diabetes or hypertension.

Technical Specifications

Model Number Minuteful Kidney
Manufacturer Healthy.io
Connectivity
Wifi Cellular
Category Urinalysis Tests
Parameters Tested Albumin, Creatinine, and Albumin-to-Creatinine Ratio (ACR)
Test Type (dipstick/cassette/digital reader) Smartphone-enabled colorimetric scan
Results Time (seconds) 180
Sensitivity & Specificity 96.4% sensitivity and 98.6% NPV for detecting albuminuria
FDA Clearance K210069, K222921
Number of Tests Per Pack 1
Shelf Life N/A (not available)
Storage Requirements Room temperature

Cost & Coverage Analysis

Pricing Breakdown

Kit Cost (1 kit per box)
Free

HSA / FSA Eligibility

Usually Eligible

Eligibility may vary by provider and plan. Check with your HSA/FSA administrator for specific details.

Clinical Review

Evidence-based evaluation by medical professionals

"The Minuteful Kidney Test is the only home-use ACR test with validated clinical-grade performance and seamless smartphone integration."
Strong Clinical Evidence Highly Recommended
94
Score

The Minuteful Kidney Test by Healthy.io is a prescription-use diagnostic system that transforms a standard smartphone into a clinical-grade urine analyzer. It is specifically designed for early warning of chronic kidney disease (CKD) in high-risk populations, including those with diabetes or hypertension. The system uses advanced computer vision to interpret urine reagent strips with a physical calibration 'Color-Board,' effectively replicating the accuracy of laboratory analyzers. In clinical trials involving 555 patients, the device demonstrated a sensitivity of 96.4% and a negative predictive value of 98.6% for detecting albuminuria. The testing process takes approximately three minutes, and results are shared directly with healthcare providers through an integrated clinical portal, facilitating early medical intervention.

Comparative Performance

Highest-rated device in Urinalysis Tests category

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Minuteful Kidney Test (Healthy.io)

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Current Top Rated
94 /100
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Labcorp OnDemand UTI Test Kit

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Pelvana Urinary Tract Infection Test Strips

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Highest Clinical Rating

This device achieved the highest overall score among 18 clinically evaluated urinalysis tests devices, demonstrating superior performance across key testing protocols and real-world validation metrics.

Where to Buy

Verified retailers and current pricing

Healthcare Provider Systems

Varies by provider

Prescription required; distributed through participating health systems.

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Important Information

  • • Prices and availability subject to change
  • • Some devices may require a prescription
  • • HSA / FSA eligibility: Usually Eligible
  • • Purchase from authorized retailers for warranty protection
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