Cleared Traditional

Tru Kidney Health Test Panel; Tru Analyzer

K251058 · Truvian Health · Chemistry
Nov 2025
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K251058 is an FDA 510(k) clearance for the Tru Kidney Health Test Panel; Tru Analyzer, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on November 26, 2025, 236 days after receiving the submission on April 4, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K251058 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2025
Decision Date November 26, 2025
Days to Decision 236 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

Similar Devices — CGX Alkaline Picrate, Colorimetry, Creatinine

All 158
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206 · Nova Biomedical Corporation · Jan 2026
Atellica? CH Creatinine_3 (Crea3)
K242685 · Siemens Healthcare Diagnostics, Inc. · Dec 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · Nova Biomedical Corporation · Nov 2024
Creatinine2
K210452 · Abbott Ireland Diagnostics Division · Mar 2022
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494 · Siemens Healthcare Diagnostics, Inc. · Nov 2016
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · Siemens Healthcare Diagnostics, Inc. · Jan 2014