510(k) · Cleared
ClearedTriVerity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inflammatix, Inc. · PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Cleared on Jan 10, 2025 as substantially equivalent to K203748 (Immunexpress, Inc., 2021) after a 213-day review. Its family tree reaches back 3 generations to 2016.
- Decided
- Jan 10, 2025
- Review
- 213 days
- Class
- Class II
- Product code
- PRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150009 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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 K203748 SeptiCyte RAPIDscore 5.7 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203748 | SeptiCyte RAPIDSummary page 8…K241676 10.0 SUBSTANTIAL EQUIVALENCE Predicate Device Name: SeptiCyte RAPID Predicate 510(k) Number: K203748 Comparison with Predicate: Table 1: Comparison with Predicate… | 2021 |
| † | K042613 | PAXgene Blood RNA System |
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.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a 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. 2025, 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 TriVerity test is an automated, semi-quantitative in vitro diagnostic test that measures the relative expression levels of host response genes in RNA isolated from whole blood collected in the PAXgene Blood RNA tube using reverse transcription loop-mediated isothermal amplification (RT-LAMP) on the Myrna instrument. The TriVerity test is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to…
Read the full statement (154 words)
The TriVerity test is an automated, semi-quantitative in vitro diagnostic test that measures the relative expression levels of host response genes in RNA isolated from whole blood collected in the PAXgene Blood RNA tube using reverse transcription loop-mediated isothermal amplification (RT-LAMP) on the Myrna instrument.
The TriVerity test is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial infections, viral infections, and non-infectious illness, as well as to determine the likelihood of 7-day need for mechanical ventilation, vasopressors, and/or renal replacement therapy in adult patients with suspected acute infection or suspected sepsis presenting to the emergency department.
The test generates three scores that each fall within one of five discrete interpretation bands based on the increasing likelihood of
1) bacterial infection,
2) viral infection, and
3) severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241676: TriVerity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241676
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026