510(k) K250912
K250912 is an FDA 510(k) premarket notification submitted by Cytovale, Inc. for the device "IntelliSep Test". The FDA issued a decision of Substantially Equivalent on Nov 19, 2025. The device falls under product code QUT (Deformability Cytometry For Sepsis Risk Assessment), a Class II device regulated under 21 CFR 866.3215. Cytovale, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 19, 2025
- Date Received
- Mar 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Deformability Cytometry For Sepsis Risk Assessment
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
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