Minuteful - kidney test let lay users test their own urine albumin

In FDA's review of the Minuteful - kidney test, all 466 lay users tested their own urine with a smartphone. Their ACR results matched a trained operator's in 92.7% of cases.

  • 2 a person

    Lay users with no training tested their own urine, and 92.7% of their ACR results matched a trained operator's.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

A trained operator testing the same urine on the predicate device. Measured.

The system’s part
Not isolated. The study compared lay users' results on the device with a trained operator's results on the predicate reader. It did not compare testing with and without the algorithm. The summary describes an image recognition algorithm on a cloud server and does not say whether it learned from data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

Download data Cite Suggest a correction

Benefit type
Improved Accessibility
System
Minuteful - kidney test
Made by
Healthy.io Ltd.
Used by
Healthy.io (method comparison with 466 lay users)
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Estimating the Quantifiable Characteristics of Products, Events, or Information, Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary for Minuteful - kidney test (K210069). Cleared 2022-07-06.

    All 466 study participants (100%) completed the Minuteful - kidney test using only the user manual provided in the kit and the device in-app guides to test their own urine.

Details

AI system

Workflow

Users followed the user manual and in-app prompts on an iPhone 11 or a Google Pixel 3a. The kit held a URiSCAN 2 ACR urine strip and a single-use Color-Board.

Follow-up

Conditions for replication

The user has a prescription and is at risk of kidney disease. Results are used with clinical evaluation as an aid in assessing kidney health.

Entry details

Sector

Healthcare.

Purpose

Healthy.io built the Minuteful - kidney test so that people at risk of kidney disease can measure their urine albumin-creatinine ratio at home with a smartphone.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Minuteful - kidney test let lay users test their own urine albumin (AIBD-0809). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0809.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

BibTeX Data Field definitions