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U.S. Department of Health and Human Services

Product Classification

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Device assay to measure pct to aid in the risk assessment of critically ill patients on their first day of icu admission
Definition Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock
Physical State In vitro diagnostic device
Technical Method Latex particle enhanced immunoturbidimetric method intended for the quantitative determination of PCT in serum, EDTA or lithium heparin plasma.
Target Area Detection and determination of procalcitonin (PCT) concentration in serum or plasma
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePTF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3215
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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