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U.S. Department of Health and Human Services

Product Classification
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Device rt-qpcr assay for mrna transcript immune biomarkers
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 quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.
Physical State In vitro diagnostic device.
Technical Method Reverse transcription + quantitative PCR(RT-qPCR)
Target Area Whole blood collected in RNA collection tube.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePRE
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		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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