QUT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Deformability Cytometry For Sepsis Risk Assessment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA 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
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| Record | Firm | Date |
|---|---|---|
| IntelliSep Test (K250912) | Cytovale, Inc. | 2025-11-19 |
| IntelliSep Test (CV-ICG-048) (K250513) | Cytovale, Inc. | 2025-03-21 |
| IntelliSep test (K220991) | Cytovale, Inc. | 2022-12-20 |
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Every clearance here is in the API, with alerts when new ones post.