510(k) · Cleared
ClearedSeptiCyte RAPID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunexpress, Inc. · PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Cleared on Dec 15, 2023 after a 155-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 15, 2023
- Review
- 155 days
- Class
- Class II
- Product code
- PRE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PRE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PRE device
- #1 K241676 TriVerityscore 9.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PRE devicesPRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PRE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PRE
Too few PRE 510(k)s in any year since 2007 to give a median.
Recalls per year · PRE
No recall names PRE since 2007.
Adverse event reports per year · PRE
No MAUDE report names PRE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from…
Read the full statement (119 words)
The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K232095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232095: SeptiCyte RAPID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232095
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026