Device |
deformability cytometry for sepsis risk assessment |
Regulation Description |
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis. |
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 |
Physical State |
The device is an analyzer which probes physical properties of leukocytes by exposing cells to a shear flow in a microfluidic channel |
Technical Method |
Clinical whole blood specimen is measured in an automated analyzer system |
Target Area |
Clinical whole blood specimen |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QUT |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3215
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |