Cleared Traditional

Lipids (K251091) - FDA 510(k) Clearance

Class I Chemistry device.

K251091 · Truvian Health · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
264d
Days
Class 1
Risk

K251091 is an FDA 510(k) clearance for the Lipids. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on December 30, 2025 after a review of 264 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Truvian Health devices

Submission Details

510(k) Number K251091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2025
Decision Date December 30, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 88d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 64
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K251091.
CHOLESTEROL
K232404 · Medicon Hellas S.A · Aug 2024
Cholesterol2
K203597 · Abbott Ireland Diagnostics Division · Jun 2022
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
Extended Lipid Panel Assay
K181373 · Laboratory Corporation of America Holdings · Oct 2018
Mission Lipid Panel Monitoring System
K180504 · ACON Laboratories, Inc. · Mar 2018
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · ACON Laboratories, Inc. · Jul 2017