Cleared Traditional

K251058 - Tru Kidney Health Test Panel

Also marketed or referenced as:
Tru Analyzer

K251058 is an FDA 510(k) clearance for Tru Kidney Health Test Panel, manufactured by Truvian Health. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K251058 · Truvian Health · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
236d
Days
Class 2
Risk

K251058 is an FDA 510(k) clearance for the Tru Kidney Health Test Panel. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on November 26, 2025 after a review of 236 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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

FDA 510(k) Submission Details - K251058

510(k) Number K251058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 88d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 120
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K251058.
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