Deformability Cytometry For Sepsis Risk Assessment
The Deformability Cytometry for Sepsis Risk Assessment is a semi-quantitative in vitro diagnostic assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid in the early detection of sepsis, a life-threatening systemic infection response. Changes in leukocyte deformability are associated with immune activation during sepsis. Classified as FDA Class 2 under regulation 866.3215, it requires 510(k) clearance in the Microbiology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QUT
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.