Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6316](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6316) → SAK — Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

# SAK · Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

_General Hospital · 21 CFR 880.6316 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/SAK

## Overview

- **Product Code:** SAK
- **Device Name:** Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- **Regulation:** [21 CFR 880.6316](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6316)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

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 Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230036](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/SAK/DEN230036.md) | Sepsis ImmunoScore | Prenosis, Inc. | Apr 2, 2024 | DENG |

## Top Applicants

- Prenosis, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/SAK](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/SAK)

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