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U.S. Department of Health and Human Services

Product Classification
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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 CodeQUT
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
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