Lipids

FDA 510(k) K251091 · Truvian Health

Substantially Equivalent

510(k) numberK251091

Submission

Device name
Lipids
Applicant
Truvian Health
San Diego, CA, US
Received
April 10, 2025
Decision date
December 30, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CHH – Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Specialty
Clinical Chemistry

Other 510(k)s with product code CHH

510(k)DeviceApplicantDecision
K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional Medicon Hellas S.A08/09/2024SE
K203597Cholesterol2CHH · Traditional Abbott Ireland Diagnostics Division06/30/2022SE
K190490VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional Ortho-Clinical Diagnostics, Inc.03/27/2019SE
K181373Extended Lipid Panel AssayCHH · Traditional Laboratory Corporation of America Holdings10/18/2018SE
K180504Mission Lipid Panel Monitoring SystemCHH · Special ACON Laboratories, Inc.03/28/2018SE
K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional ACON Laboratories, Inc.07/11/2017SE
K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional Polymer Technology Systems, Inc.12/22/2016SE
K150654CholesterolCHH · Traditional Randox Laboratories, Ltd.09/29/2015SE
K132031Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional Axis-Shield Poc AS03/21/2014SE
K130200Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional Abaxis, Inc.02/15/2013SE

More from Abaxis, Inc.

510(k)DeviceDecision
K251157Core MetabolicCIX · Traditional 01/09/2026SE
K251074Tru Liver Health Test PanelCJE · Traditional 12/19/2025SE
K251058Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional 11/26/2025SE

Questions and answers

When was Lipids cleared by the FDA?

Lipids (K251091) received a 510(k) decision of Substantially Equivalent on December 30, 2025, 264 days after the submission was received.

What is the product code of K251091?

The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.