FDA product code PRE: Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
PRE is the FDA product code for rt-qpcr assay for mrna transcript immune biomarkers. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under PRE, 2 in the last five years, from 2 different applicants. The average 510(k) review took 199 days (median 184); 213 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PRE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 88 |
| 2021 | 1 | 341 |
| 2023 | 1 | 155 |
| 2025 | 1 | 213 |
Compare with all 510(k) review times · Search every PRE clearance
Top PRE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunexpress, Inc. | 3 | 2023-12-15 |
| Inflammatix, Inc. | 1 | 2025-01-10 |
Most recent PRE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241676 | Inflammatix, Inc. | TriVerity | 2025-01-10 | 213 |
| K232095 | Immunexpress, Inc. | SeptiCyte RAPID | 2023-12-15 | 155 |
| K203748 | Immunexpress, Inc. | SeptiCyte RAPID | 2021-11-29 | 341 |
| K163260 | Immunexpress, Inc. | SeptiCyte LAB | 2017-02-17 | 88 |
Recalls for PRE devices
openFDA lists no recalls for product code PRE.
Frequently asked questions
What is FDA product code PRE?
PRE is the FDA product code for rt-qpcr assay for mrna transcript immune biomarkers. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is PRE?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code PRE?
Across 4 cleared submissions the average was 199 days from receipt to decision (median 184).
Which companies have the most PRE clearances?
Immunexpress, Inc. (3); Inflammatix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PRE
- Run a recall and safety report across every PRE manufacturer
- Watch product code PRE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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