K220991 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. (San Francisco, US). The FDA issued a Cleared decision on December 20, 2022, 260 days after receiving the submission on April 4, 2022.
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 | K220991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | December 20, 2022 |
| Days to Decision | 260 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 |