Minuteful - kidney test is an AI-enabled medical device from Healthy.io Ltd. that the U.S. FDA cleared through 510(k) K210069 on July 6, 2022. Its lead review panel is Clinical Chemistry and its primary product code is JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)).
See also all FDA AI clearances in 2022.
Key facts
| Submission number | K210069 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Healthy.io Ltd. |
| Lead review panel | Clinical Chemistry |
| Primary product code | JIR — Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Applicant (openFDA) | Healthy.Io, Ltd. |
| Applicant location | Tel Aviv, IL |
| Device class | Class 1 |
| Regulation number | 21 CFR 862.1645 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Minuteful - kidney test went through this pathway (K210069).
openFDA lists it as a Class 1 device under 21 CFR 862.1645. Class I devices are low risk and are mostly subject to general controls.
Product code JIR covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Healthy.io Ltd. has 4 AI-enabled devices on the list, and the Clinical Chemistry panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.