Cleared Traditional

K251058 - Tru Kidney Health Test Panel (FDA 510(k) Clearance)

Also includes:
Tru Analyzer

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 158
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