General Hospital · De Novo · 2024
Sepsis ImmunoScore
Prenosis, Inc.. Granted by FDA on 2 April 2024 under submission DEN230036, product code SAK (software device to aid in the prediction or diagnosis of sepsis). What FDA's record says, in FDA's words.
Device record · DEN230036
- Device. Sepsis ImmunoScoreDEVICE
- Company. Prenosis, Inc.COMPANY
- Decision. 2 April 2024, De NovoDECISION
- Panel. General HospitalPANEL
- Product code. SAK, Software Device To Aid In The Prediction Or Diagnosis Of SepsisCODE
- Regulation. 21 CFR 880.6316, Class IIREG
- Source. FDA database entry · decision document (47 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The Sepsis ImmunoScore is indicated as follows: The Sepsis ImmunoScore is an Artificial Intelligence/Machine Learning (AI/ML)-Based Software that identifies patients at risk for having or developing sepsis. The Sepsis ImmunoScore uses up to 22 predetermined inputs from the patient's electronic health record to generate a risk score and to assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis. The Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for presence of or progression to sepsis within 24 hours of patient assessment. It is intended to be used for patients admitted to the Emergency Department or hospital for whom sepsis is suspected, and a blood culture was ordered as part of the evaluation for sepsis. It should not be used as the sole basis to determine the presence of sepsis or risk of developing sepsis within 24 hours.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 35 reports filed against devices carrying product code SAK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
23 September 2026 · Malfunction · Sepsis · Cerner Corporation · report 1931259-2026-00018
On August 25, 2026, Cerner became aware of a temporary third-party network interruption affecting the Sepsis service. During the interruption, processing of Sepsis outcomes and delivery of notifications were delayed. The issue was resolved, processing resumed, and all delayed items were processed. Customers were notified during the event and instructed to manually monitor patients for sepsis while notifications were delayed. No patient adverse events were reported in connection with this […]
7 August 2026 · Malfunction · Sepsis · Cerner Corporation · report 1931259-2026-00016
7 August 2026 · Malfunction · Sepsis · Cerner Corporation · report 1931259-2026-00015
29 June 2026 · Malfunction · SEPSIS · CERNER CORPORATION · report 1931259-2026-00014
ON (B)(6) 2026, A SINGLE CUSTOMER EXPERIENCED DELAYED SEPSIS PROCESSING DUE TO A PROCESSING STALL, RESULTING IN A BACKLOG AND DELAYED PROCESSING FOR APPROXIMATELY 2 HOURS AND 26 MINUTES. FOLLOWING REMOVAL OF THE RECORD ASSOCIATED WITH THE PROCESSING STALL, NORMAL PROCESSING RESUMED AND THE BACKLOG CLEARED. NO PATIENT HARM OR ADVERSE PATIENT OUTCOMES HAVE BEEN REPORTED.
24 June 2026 · Malfunction · SEPSIS · CERNER CORPORATION · report 1931259-2026-00012
ON (B)(6) 2026, A SINGLE CUSTOMER EXPERIENCED A SEPSIS PROCESSING DELAY FOLLOWING A MILLENNIUM 2026.01 UPTIME UPGRADE. INCREASED INCOMING DATA VOLUME RESULTED IN A PROCESSING BACKLOG, CAUSING A MAXIMUM DELAY OF APPROXIMATELY 3 HOURS AND 29 MINUTES. RECOVERY ACTIONS WERE IMPLEMENTED TO RESTORE NORMAL PROCESSING, AND ALL QUEUED DATA WAS SUCCESSFULLY PROCESSED AFTER INGESTION STABILIZED. THE CUSTOMER WAS NOTIFIED OF THE ISSUE. NO PATIENT HARM OR ADVERSE PATIENT OUTCOMES HAVE BEEN REPORTED.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SAK, in General Hospital, or granted in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.