FDA product code QUT: Deformability Cytometry For Sepsis Risk Assessment
QUT is the FDA product code for deformability cytometry for sepsis risk assessment. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QUT, 3 in the last five years. The average 510(k) review took 175 days (median 237); 132 days on average over the last three years.
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
Classification
| Field | Value |
|---|---|
| Device name | Deformability Cytometry For Sepsis Risk Assessment |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QUT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 260 |
| 2025 | 2 | 132 |
Compare with all 510(k) review times · Search every QUT clearance
Top QUT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytovale, Inc. | 3 | 2025-11-19 |
Most recent QUT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250912 | Cytovale, Inc. | IntelliSep Test | 2025-11-19 | 237 |
| K250513 | Cytovale, Inc. | IntelliSep Test (CV-ICG-048) | 2025-03-21 | 28 |
| K220991 | Cytovale, Inc. | IntelliSep test | 2022-12-20 | 260 |
Recalls for QUT devices
openFDA lists no recalls for product code QUT.
Frequently asked questions
What is FDA product code QUT?
QUT is the FDA product code for deformability cytometry for sepsis risk assessment. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is QUT?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUT?
Across 3 cleared submissions the average was 175 days from receipt to decision (median 237).
Which companies have the most QUT clearances?
Cytovale, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QUT
- Run a recall and safety report across every QUT manufacturer
- Watch product code QUT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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