KidneyIntelX.dkd is an AI-enabled medical device from Renalytix AI, Inc. that the U.S. FDA granted through De Novo DEN200052 on June 29, 2023. Its lead review panel is Clinical Chemistry and its primary product code is QWZ (Prognostic Test For Assessment Of Chronic Kidney Disease Progression).
See also all FDA AI clearances in 2023.
Key facts
| Submission number | DEN200052 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Renalytix AI, Inc. |
| Lead review panel | Clinical Chemistry |
| Primary product code | QWZ — Prognostic Test For Assessment Of Chronic Kidney Disease Progression |
| Applicant (openFDA) | Renalytix Ai, Inc. |
| Applicant location | New York, NY, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.1223 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. KidneyIntelX.dkd went through this pathway (DEN200052).
openFDA lists it as a Class 2 device under 21 CFR 862.1223. Class II devices are moderate risk and are subject to general and special controls.
Product code QWZ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Renalytix AI, Inc. has 1 AI-enabled device 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.