Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
SAK · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6316
Classification
FDA Product Code
SAK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6316
Review panel
GU
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.