Cleared Special

IntelliSep Test (CV-ICG-048)

K250513 · Cytovale, Inc. · Microbiology
Mar 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K250513 is an FDA 510(k) clearance for the IntelliSep Test (CV-ICG-048), 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 March 21, 2025, 28 days after receiving the submission on February 21, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K250513 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2025
Decision Date March 21, 2025
Days to Decision 28 days
Submission Type Special
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