Sepsis ImmunoScore is an AI-enabled medical device from Prenosis, Inc. that the U.S. FDA granted through De Novo DEN230036 on April 2, 2024. Its lead review panel is General Hospital and its primary product code is SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | DEN230036 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Prenosis, Inc. |
| Lead review panel | General Hospital |
| Primary product code | SAK — Software Device To Aid In The Prediction Or Diagnosis Of Sepsis |
| Applicant (openFDA) | Prenosis, Inc. |
| Applicant location | Chicago, IL, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 880.6316 |
| 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. Sepsis ImmunoScore went through this pathway (DEN230036).
openFDA lists it as a Class 2 device under 21 CFR 880.6316. Class II devices are moderate risk and are subject to general and special controls.
Product code SAK covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Prenosis, Inc. has 1 AI-enabled device on the list, and the General Hospital panel accounts for 6 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.