DeviceClearance

Product code QUT— Microbiology

IntelliSep Test

Classification name
Deformability Cytometry For Sepsis Risk Assessment
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code QUT under 21 CFR 866.3215, via openFDA

Market context for product code QUT

FDA has cleared 3 devices under product code QUT between 2022 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QUT

Recent clearances under product code QUT

Data sourced from openFDA. This site is unofficial and independent of the FDA.