# K220991: IntelliSep test

- Pathway: 510(k) (Traditional)
- Applicant: Cytovale, Inc.
- Decided: Dec 20, 2022 after 260 days
- Product code: QUT (Deformability Cytometry For Sepsis Risk Assessment)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K071146 (2007). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162827: Vidas B.R.a.H.M.S. PCT (PCT), bioMerieux, Inc. (2017) Summary page 4.

## Most influential descendants
- K250912: IntelliSep Test (2025), 0 descendants of its own
- K250513: IntelliSep Test (CV-ICG-048) (2025), 0 descendants of its own

## Indications for use
The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample. The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The IntelliSep test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgement. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis. The IntelliSep test is intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K220991
Methodology: https://510kreport.com/methodology