IDx-DR is an AI-enabled medical device from IDx, LLC that the U.S. FDA granted through De Novo DEN180001 on April 11, 2018. Its lead review panel is Ophthalmic and its primary product code is PIB (Diabetic Retinopathy Detection Device).
See also all FDA AI clearances in 2018.
Key facts
| Submission number | DEN180001 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | IDx, LLC |
| Lead review panel | Ophthalmic |
| Primary product code | PIB — Diabetic Retinopathy Detection Device |
| Applicant (openFDA) | Idx, LLC |
| Applicant location | Iowa City, IA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 886.1100 |
| 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. IDx-DR went through this pathway (DEN180001).
openFDA lists it as a Class 2 device under 21 CFR 886.1100. Class II devices are moderate risk and are subject to general and special controls.
Product code PIB covers 7 devices on the FDA AI list. By decision date, this device is #1 of 7 under that code. IDx, LLC has 1 AI-enabled device on the list, and the Ophthalmic panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.