# DEN230036: Sepsis ImmunoScore

- Pathway: De Novo (Direct)
- Applicant: Prenosis, Inc.
- Decided: Apr 2, 2024 after 333 days
- Product code: SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis)
- Device class: 2
- Regulation: 21 CFR 880.6316
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K250680: Bayesian Health Sepsis Flagging Device (2026), 0 descendants of its own

## Indications for use
The Sepsis ImmunoScore is an Artificial Intelligence/Machine Learning (AI/ML)-Based Software that identifies patients at risk for having or developing sepsis. The Sepsis ImmunoScore uses up to 22 predetermined inputs from the patient’s electronic health record to generate a risk score and to assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis. The Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for presence of or progression to sepsis within 24 hours of patient assessment. It is intended to be used for patients admitted to the Emergency Department or hospital for whom sepsis is suspected, and a blood culture was ordered as part of the evaluation for sepsis. It should not be used as the sole basis to determine the presence of sepsis or risk of developing sepsis within 24 hours.

Source page: https://510kreport.com/device/DEN230036
Methodology: https://510kreport.com/methodology