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U.S. Department of Health and Human Services

Product Classification
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Device immunoassay for host biomarkers to predict risk of 28-day all-cause mortality in patients with sepsis and septic shock.
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 immunoassay used to detect host biomarkers as an aid to assess the risk of 28-day all-cause mortality in patients with sepsis and septic shock.
Physical State In Vitro Diagnostic Device
Technical Method Immunoassay
Target Area Detection of host biomarker in human clinical samples
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeSJQ
Premarket Review Division of Microbiology Devices (DMD)
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
Accredited Persons
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