Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
The RT-qPCR Assay for mRNA Transcript Immune Biomarkers is 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, used to assess immune biomarker profiles. It is classified as FDA Class 2 under 21 CFR 866.3215 in the Microbiology specialty, requiring 510(k) premarket notification. The device provides information on host immune response to support clinical decision-making. Product code PRE; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PRE
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241676 | TriVerity | Jan 10, 2025 | Substantially Equivalent | Inflammatix, Inc. |
| K232095 | SeptiCyte RAPID | Dec 15, 2023 | Substantially Equivalent | Immunexpress, Inc. |
| K203748 | SeptiCyte RAPID | Nov 29, 2021 | Substantially Equivalent | Immunexpress, Inc. |
| K163260 | SeptiCyte LAB | Feb 17, 2017 | Substantially Equivalent | Immunexpress, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.