DEN230036 is an FDA 510(k) submission for the Sepsis ImmunoScore. This device is classified as a Software Device To Aid In The Prediction Or Diagnosis Of Sepsis (Class II - Special Controls, product code SAK).
Submitted by Prenosis, Inc. (Chicago, US). The FDA issued a Not Cleared (DENG) decision on April 2, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 880.6316. 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..
| 510(k) Number | DEN230036 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 05, 2023 |
| Decision Date | April 02, 2024 |
| Days to Decision | 333 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | SAK - Software Device To Aid In The Prediction Or Diagnosis Of Sepsis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6316 |
| 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. |