SAK — Software Device To Aid In The Prediction Or Diagnosis Of Sepsis Class II

FDA Device Classification

Classification Details

Product Code
SAK
Device Class
Class II
Regulation Number
880.6316
Submission Type
Review Panel
GU
Medical Specialty
General Hospital
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN230036prenosisSepsis ImmunoScoreApril 2, 2024