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U.S. Department of Health and Human Services

Product Classification

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Device device to detect and measure procalcitonin (pct) in human clinical specimens
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 assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
Physical State In vitro diagnostic device
Technical Method Immunoassay, ELISA
Target Area Detection and determination the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma specimens.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePMT
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