IntelliSep Test (CV-ICG-048)

The IntelliSep Test is a rapid sepsis detection device that analyzes leukocyte biophysical properties using deformability cytometry on whole blood samples. It generates an IntelliSep Index score stratified into three interpretation bands to aid in early detection of sepsis with organ dysfunction within 3 days, intended for adult patients with signs of infection presenting to the Emergency Department.

The modified device (K250513) adds an optional external network connection for remote log export without incoming data or patient information, refines internal quality control metrics to improve clog detection and assay failure discernment, and introduces an alternative Imaging Analysis Module hardware configuration with equivalent processing capabilities but reduced power supplies. The underlying cell deformability cytometry technique and IntelliSep result calculation remain unchanged from the predicate K220991.

CLSI EP05-A3 (within-laboratory precision and reproducibility), CLSI EP28-A3C (healthy reference range), IEC 60601-1-2:2014/AMD1:2020 (electromagnetic compatibility), IEC 61010-1:2010/AMD1:2016 (electrical safety), IEC TS 60601-4-2 (immunity assessment), and Good Machine Learning Practice for Medical Device Development (FDA, Health Canada, MHRA, October 2021).

Substantial equivalence is supported because modifications do not change the intended use, indications, or core technological operation. Raw assay videos from clinical validation and performance studies (precision, reproducibility, reference range) processed identically on both modified and predicate devices showed no performance differences. The new IAM hardware variant maintains equivalent functional and performance requirements with no data interface changes. The refined quality control metrics showed no impact on analytical or clinical performance per the predicate's design specifications. Cybersecurity and electrical safety testing confirmed continued compliance and safety profile.