510(k) DEN230036

Sepsis ImmunoScore by Prenosis, Inc. — Product Code SAK

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 2, 2024
Date Received: May 5, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Device Class: Class II
Regulation Number: 880.6316
Review Panel: GU
Submission Type

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.