Minuteful - kidney test

K210069

Healthy.io Ltd. · cleared 2022-07-06 · product code JIR · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. “blotting”) pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities.”
Algorithmimage recognition algorithms, computer vision and machine learning algorithmic components
source quote (p.5)
“The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities.”
Adaptive (vs locked)FDA source did not state this
PCCPYes
source quote (p.7)
“Newly introduced smartphone-hardware and new operating systems will be validated by the company on a regular basis.”
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: Precision (Repeatability); Precision (Reproducibility); Interference; Limit of Detection; Linearity; Stability

standards: CLSI document EP05-A3 - Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition, CLSI document EP07: Interference Testing in Clinical Chemistry; Approved Guideline – Third Edition, CLSI EP37: Supplemental Tables for Interference Testing in Clinical Chemistry – First Edition, CLSI document EP17-A2 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guidelines - Second Edition, CLSI document EP6-A Evaluation of Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline, IEC TR 60721-4-1:2001+A1:-3, Class 2K2, IEC TR 60721-4-1:2001+A1:-3, Class 2M3

Retrospective clinical

n=450 patients

endpoints: Accuracy (exact agreement for ACR); Accuracy (exact agreement for albumin); Accuracy (exact agreement for creatinine); Usability

standards: Good Clinical Practice (GCP), 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, 21 CFR Part 812, ISO 14155-1/2, CLSI EP09c: Method Comparison and Bias Estimation Using Patient Samples; Approved Guidelines – Third Edition

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

6
recalls in product code, 24mo
2
MAUDE reports in code, 12mo
-14%
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K222921 (decision 2023-09-08) from Healthy.io Ltd. for a matching device line ("Minuteful-kidney test") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K222921

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Clinical Chemistry panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K210069