Cleared Traditional

IntelliSep Test

K250912 · Cytovale, Inc. · Microbiology
Nov 2025
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K250912 is an FDA 510(k) clearance for the IntelliSep Test, a Deformability Cytometry For Sepsis Risk Assessment (Class II — Special Controls, product code QUT), submitted by Cytovale, Inc. (South San Francisco, US). The FDA issued a Cleared decision on November 19, 2025, 237 days after receiving the submission on March 27, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K250912 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2025
Decision Date November 19, 2025
Days to Decision 237 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QUT — Deformability Cytometry For Sepsis Risk Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3215
Definition A Semi-quantitative Assay That Measures Cellular Deformability And Other Physical Properties Of Leukocytes In Whole Blood Samples To Aid The Early Detection Of Sepsis