Not Cleared Direct

DEN230036 - Sepsis ImmunoScore (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230036 · Prenosis, Inc. · Gastroenterology & Urology device
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Apr 2024
Decision
333d
Days
Class 2
Risk

DEN230036 is an FDA 510(k) submission (not cleared) for the Sepsis ImmunoScore. Classified as Software Device To Aid In The Prediction Or Diagnosis Of Sepsis (product code SAK), Class II - Special Controls.

Submitted by Prenosis, Inc. (Chicago, US). The FDA issued a Not Cleared (DENG) decision on April 2, 2024 after a review of 333 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.6316 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 333 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Prenosis, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 130d · This submission: 333d
Pathway characteristics

Device Classification

Product Code SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.