TriVerity

K241676

Inflammatix, Inc. · cleared 2025-01-10 · product code PRE · Microbiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“The TriVerity test is an in vitro diagnostic test for simultaneous amplification and detection of 29 informative host response RNA transcripts and 3 housekeeping transcripts (listed in measurands) using total RNA extracted from human blood. The expression levels of the 32 RNA transcripts measured are input to two fixed classifiers which output three separate scores, each with five discrete interpretation bands.”
Algorithmtwo fixed classifiers which output three separate scores, each with five discrete interpretation bands. The bands reflect monotonically increasing likelihood of bacterial infection, viral infection, and severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days.
source quote (p.7)
“The TriVerity test quantifies the amount of each transcript in the sample based on the detection of fluorescence by the Myrna instrument. The cartridge includes the reagents for reverse transcription and LAMP. All 32 transcripts (and two in cartridge controls) are amplified and quantified. These values are input to two fixed classifiers which output three separate scores, each with five discrete interpretation bands. The bands reflect monotonically increasing likelihood of bacterial infection, viral infection, and severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days. The expression levels of the 32 RNA transcripts measured are input to two fixed classifiers which output three separate scores, each with five discrete interpretation bands. The bands reflect monotonically increasing likelihood of bacterial infection, viral infection, and severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days.”
Adaptive (vs locked)No
source quote (p.7)
“These values are input to two fixed classifiers which output the three separate scores, each with five discrete interpretation bands.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=138 cases · 3 site(s)

endpoints: standard deviation for scores and bands; mean score shift(bias); amplification; linearity

standards: CLSI EP05-A3, CLSI EP06, CLSI EP07, CLSI EP17-A2, CLSI EP25-A, CLSI EP37, ASTM D4169-23, ASTM F2825-18

Retrospective clinical

n=1,222 patients · 22 site(s)

endpoints: diagnosing bacterial and viral infections; predicting severe illness (defined as the need for mechanical ventilation, vasopressors, or renal replacement therapy [RRT] within 7 days); likelihood ratio; Positive Percent Agreement (PPA); Negative Percent Agreement (NPA); predictive values (post-test probabilities); AUROC

Reported performance (5 observations)

sensitivity30.5
source quote (p.25)
“Very High 30.5”
specificity94.2
source quote (p.25)
“Very High 94.2”
aurocas written: “auc”0.76CI 0.75-0.78
source quote (p.30)
“Bacterial Infection (Forced Adjudication) N 1222 AUROC 0.76 Lower 80% CI 0.75 Upper 80% CI 0.78”
aurocas written: “AUROC”0.83CI 0.81-0.85
source quote (p.30)
“Viral Infection (Forced adjudication) N 1222 AUROC 0.83 Lower 80% CI 0.81 Upper 80% CI 0.85”
aurocas written: “AUROC”0.78CI 0.75-0.81
source quote (p.30)
“Severe Infection (Prognostic Endpoint) N 1120 AUROC 0.78 Lower 80% CI 0.75 Upper 80% CI 0.81”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

ntap2025-10-01

NTAP max add-on $243.75 (active) ·

CMS granted NTAP beginning FY2026 (max add-on $243.75/case) for a host-response test using machine-learning-derived algorithms on 29 mRNA transcripts to output bacterial, viral, and severity/sepsis scores; billed under ICD-10-PCS XXE5XBB. FDA 510(k) K241676 cleared 2025-01-10. Facility payment only. Dollar figure read from CMS MAC Implementation File 8.

CMS FY2026 IPPS Final Rule MAC Implementation File 8Inflammatix TriVerity NTAP press releaseopenFDA 510(k) record K241676

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Microbiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K241676