Devices · Prenosis, Inc.

Sepsis ImmunoScore

Prenosis, Inc. is listed for Sepsis ImmunoScore (DEN230036). The FDA list gives April 2, 2024 as the date of the final decision. The lead panel is General Hospital, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SAK as “Software Device To Aid In The Prediction Or Diagnosis Of Sepsis”: A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230036

Official FDA database record

Date of final decision

April 2, 2024

Company on the FDA list

Prenosis, Inc.

Lead panel

General Hospital

Primary product code

SAK

openFDA device name for the code

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Device class

2

Regulation number

880.6316

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned