Product code QUT
- Device name
- Deformability Cytometry For Sepsis Risk Assessment
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3215
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K250912 | IntelliSep Test | Cytovale, Inc. | 2025-11-19 |
| K250513 | IntelliSep Test (CV-ICG-048) | Cytovale, Inc. | 2025-03-21 |
| K220991 | IntelliSep test | Cytovale, Inc. | 2022-12-20 |