Tru Kidney Health Test Panel; Tru Analyzer

FDA 510(k) K251058 · Truvian Health

Substantially Equivalent

510(k) numberK251058

Submission

Device name
Tru Kidney Health Test Panel; Tru Analyzer
Applicant
Truvian Health
San Diego, CA, US
Received
April 4, 2025
Decision date
November 26, 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
CGX – Alkaline Picrate, Colorimetry, Creatinine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1225
Specialty
Clinical Chemistry

Other 510(k)s with product code CGX

510(k)DeviceApplicantDecision
K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track Nova Biomedical Corporation01/09/2026SE
K242685Atellica® CH Creatinine_3 (Crea3)CGX · Traditional Siemens Healthcare Diagnostics, Inc.12/04/2024SE
K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track Nova Biomedical Corporation11/19/2024SE
K210452Creatinine2CGX · Traditional Abbott Ireland Diagnostics Division03/22/2022SE
K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional Siemens Healthcare Diagnostics, Inc.11/15/2016SE
K132638Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional Siemens Healthcare Diagnostics, Inc.01/27/2014SE
K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional Siemens Healthcare Diagnostics, Inc.01/24/2014SE
K123586Easyra Creatinine ReagentCGX · Special Medica Corporation05/15/2013SE
K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated Horiba Abx SAS04/30/2012SE
K083809CreatinineCGX · Special Abbott Laboratories04/07/2009SE

More from Abbott Laboratories

510(k)DeviceDecision
K251157Core MetabolicCIX · Traditional 01/09/2026SE
K251091LipidsCHH · Traditional 12/30/2025SE
K251074Tru Liver Health Test PanelCJE · Traditional 12/19/2025SE

Questions and answers

When was Tru Kidney Health Test Panel; Tru Analyzer cleared by the FDA?

Tru Kidney Health Test Panel; Tru Analyzer (K251058) received a 510(k) decision of Substantially Equivalent on November 26, 2025, 236 days after the submission was received.

What is the product code of K251058?

The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.