# K251058: Tru Kidney Health Test Panel; Tru Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Truvian Health
- Decided: Nov 26, 2025 after 236 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973993 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242685: Atellica® CH Creatinine_3 (Crea3), Siemens Healthcare Diagnostics, Inc. (2024) Summary page 5.
- K171971: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer, Lite-On Technology Corp. H.S.P.B. (2018) Summary page 5.

## Indications for use
The Tru Kidney Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Creatinine (CRE) and Blood Urea Nitrogen (BUN) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the CRE determination, Estimated Glomerular Filtration Rate (eGFR) is calculated by the analyzer. The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in diagnosing the following disorders in adults 18 years of age or older: Creatinine (CRE): Renal disease and monitoring of renal dialysis. Blood Urea Nitrogen (BUN): Certain renal and metabolic diseases. The Tru Analyzer is an automated, multi-assay integrated system, containing an absorbance reader, a bead scanner, and a cell imager for in vitro diagnostic use. This analyzer is intended for the quantitative determination of various analyte concentrations found in lithium-heparinized venous whole blood. It is for clinical laboratory or point-of-care use. Use only TruWellness Panel™ test kits with the Tru Analyzer.

Source page: https://510kreport.com/device/K251058
Methodology: https://510kreport.com/methodology