Paige Prostate is an AI-enabled medical device from Paige.AI that the U.S. FDA granted through De Novo DEN200080 on September 21, 2021. Its lead review panel is Pathology and its primary product code is QPN (Software Algorithm Device To Assist Users In Digital Pathology).
See also all FDA AI clearances in 2021.
Key facts
| Submission number | DEN200080 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Paige.AI |
| Lead review panel | Pathology |
| Primary product code | QPN — Software Algorithm Device To Assist Users In Digital Pathology |
| Applicant (openFDA) | Paige.Ai |
| Applicant location | New York, NY, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.3750 |
| 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. Paige Prostate went through this pathway (DEN200080).
openFDA lists it as a Class 2 device under 21 CFR 864.3750. Class II devices are moderate risk and are subject to general and special controls.
Product code QPN covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Paige.AI has 1 AI-enabled device on the list, and the Pathology 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.