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U.S. Department of Health and Human Services

Product Classification

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Device monocyte distribution width quantitative measurement 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 An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis.
Physical State The device is an analyzer which uses a scatterplot of light scatter correlated to the volume of the cells to identify the monocyte population
Technical Method Clinical whole blood specimen is measured in an automated cellular analyzer system
Target Area Clinical whole blood specimen
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQFS
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible