Cleared Traditional

K220991 - IntelliSep test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence.

K220991 · Cytovale, Inc. · Microbiology device
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Dec 2022
Decision
260d
Days
Class 2
Risk

K220991 is an FDA 510(k) clearance for the IntelliSep test. Classified as Deformability Cytometry For Sepsis Risk Assessment (product code QUT), Class II - Special Controls.

Submitted by Cytovale, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 20, 2022 after a review of 260 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cytovale, Inc. devices

Submission Details

510(k) Number K220991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date December 20, 2022
Days to Decision 260 days
Submission Type Traditional
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
158d slower than avg
Panel avg: 102d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04933760 Unknown Observational Industry-sponsored

CV-SQuISH-ED: Clinical Validation Study

CV-SQuISH-ED: A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department

599
Patients (actual)
4
Sites
Condition studied Sepsis; Infection
Eligibility All sexes · 18 Years+
Principal investigator Tonya Jagneaux, MD
Sponsor Cytovale, Inc. (industry)
Started 2021-05-18 → Primary completion 2022-01-13 → Completed 2022-05-01
Primary outcome
IntelliSep Index versus Retrospective Physician Diagnosis (RPD) per the sepsis 3 definition
View full study on ClinicalTrials.gov