K203748 is an FDA 510(k) clearance for the SeptiCyte RAPID. This device is classified as a Rt-qpcr Assay For Mrna Transcript Immune Biomarkers (Class II - Special Controls, product code PRE).
Submitted by Immunexpress, Inc. (Seattle, US). The FDA issued a Cleared decision on November 29, 2021, 341 days after receiving the submission on December 23, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. 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..
| 510(k) Number | K203748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | November 29, 2021 |
| Days to Decision | 341 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PRE - Rt-qpcr Assay For Mrna Transcript Immune Biomarkers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| 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. |