Cleared Traditional

IntelliSep test

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

About This 510(k) Submission

K220991 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. (San Francisco, US). The FDA issued a Cleared decision on December 20, 2022, 260 days after receiving the submission on April 4, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K220991 FDA.gov
FDA Decision Cleared 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

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