K232095 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 December 15, 2023, 155 days after receiving the submission on July 13, 2023.
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 | K232095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| 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. |