Clinical Chemistry · 510(k) · 2023
Minuteful-kidney test
Healthy.io Ltd.. Cleared by FDA on 8 September 2023 under submission K222921, product code JIR (indicator method, protein or albumin (urinary, non-quant.)). What FDA's record says, in FDA's words.
Device record · K222921
- Device. Minuteful-kidney testDEVICE
- Company. Healthy.io Ltd. (IL)COMPANY
- Decision. 8 September 2023, 510(k), substantially equivalent (traditional review); received 26 September 2022DECISION
- Panel. Clinical ChemistryPANEL
- Product code. JIR, Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)CODE
- Regulation. 21 CFR 862.1645, Class IREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 44 reports filed against devices carrying product code JIR. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-53643
21 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-46915
This summary report covers malfunction events that occurred between July 1 and September 30, 2023. This VMSR summarizes one malfunction event involving two bottles of Medline urine reagent strips (catalog number MPHUA10SG). The account reported that the strips produced a false-positive result. No physical samples, photographs, videos, or requested additional information were received; therefore, the reported malfunction could not be confirmed and the cause was not established. No patient […]
7 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-33071
4 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-32726
It was reported that "the Reagent Strips with the Lot # of98124080005 with expiration of (b)(6) 2026, were defective. All the strips inside were already showing the Leukocytes at a +1."
4 September 2026 · Malfunction · Atellica CH Microalbumin_2 (¿ALB_2) · Siemens Healthcare Diagnostics Inc. · report 2432235-2026-00215
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JIR, in Clinical Chemistry, from Healthy.io Ltd., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.