510(k) K250513

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

March 21, 2025

Date Received

February 21, 2025

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Deformability Cytometry For Sepsis Risk Assessment

Device Class

Class II

Regulation Number

866.3215

Review Panel

MI

Submission Type

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