Cleared Special

K250513 - IntelliSep Test (CV-ICG-048) (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K250513 is an FDA 510(k) clearance for the IntelliSep Test (CV-ICG-048). Classified as Deformability Cytometry For Sepsis Risk Assessment (product code QUT), Class II - Special Controls.

Submitted by Cytovale, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 21, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cytovale, Inc. devices

Submission Details

510(k) Number K250513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QUT Deformability Cytometry For Sepsis Risk Assessment
Device Class Class 2 - 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
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 Microbiology devices follow this clearance model.