FDA Product Code QUT: Deformability Cytometry For Sepsis Risk Assessment
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
Leading manufacturers include Cytovale, Inc..
FDA 510(k) Cleared Deformability Cytometry For Sepsis Risk Assessment Devices (Product Code QUT)
About Product Code QUT - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QUT since 2022, with 3 receiving FDA clearance (average review time: 175 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QUT have taken an average of 133 days to reach a decision - down from 260 days historically, suggesting improved FDA processing for this classification.
QUT devices are reviewed by the Microbiology panel. Browse all Microbiology devices →