Microbiology · 510(k) · 2025
TriVerity
Inflammatix, Inc.. Cleared by FDA on 10 January 2025 under submission K241676, product code PRE (rt-qpcr assay for mrna transcript immune biomarkers). What FDA's record says, in FDA's words.
Device record · K241676
- Device. TriVerityDEVICE
- Company. Inflammatix, Inc.COMPANY
- Decision. 10 January 2025, 510(k), substantially equivalent (traditional review); received 11 June 2024DECISION
- Panel. MicrobiologyPANEL
- Product code. PRE, Rt-Qpcr Assay For Mrna Transcript Immune BiomarkersCODE
- Regulation. 21 CFR 866.3215, Class IIREG
- Source. FDA database entry · decision document (47 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PRE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
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