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.
| Device Type ID | 3577 |
| Device Name | Rt-qpcr Assay For Mrna Transcript Immune Biomarkers |
| Physical State | In Vitro Diagnostic Device. |
| Technical Method | Reverse Transcription + Quantitative PCR(RT-qPCR) |
| Target Area | Whole Blood Collected In RNA Collection Tube. |
| Regulation Description | Device To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3215 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PRE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |