K250912 is an FDA 510(k) clearance for the IntelliSep Test. This device is classified as a Deformability Cytometry For Sepsis Risk Assessment (Class II - Special Controls, product code QUT).
Submitted by Cytovale, Inc. (South San Francisco, US). The FDA issued a Cleared decision on November 19, 2025, 237 days after receiving the submission on March 27, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. 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) Number | K250912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2025 |
| Decision Date | November 19, 2025 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QUT - Deformability Cytometry For Sepsis Risk Assessment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| 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 |