Cleared Traditional

K241676 - TriVerity (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence.

K241676 · Inflammatix, Inc. · Microbiology device
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Jan 2025
Decision
213d
Days
Class 2
Risk

K241676 is an FDA 510(k) clearance for the TriVerity. Classified as Rt-qpcr Assay For Mrna Transcript Immune Biomarkers (product code PRE), Class II - Special Controls.

Submitted by Inflammatix, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 10, 2025 after a review of 213 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inflammatix, Inc. devices

Submission Details

510(k) Number K241676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2024
Decision Date January 10, 2025
Days to Decision 213 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 102d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PRE Rt-qpcr Assay For Mrna Transcript Immune Biomarkers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03606382 Completed Observational Industry-sponsored

Collection of Clinical Specimens From Volunteers for Assay Development

6
Patients (actual)
1
Site
Condition studied Acute Respiratory Infection
Eligibility All sexes · 1 Year+
Sponsor Inflammatix (industry)
Started 2018-04-01 → Primary completion 2019-05-01
Primary outcome
Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov