# K251074: Tru Liver Health Test Panel

- Pathway: 510(k) (Traditional)
- Applicant: Truvian Health
- Decided: Dec 19, 2025 after 255 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942782 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 Liver Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. The Tru Liver 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: Alkaline Phosphatase (ALP): Liver, bone, parathyroid, and intestinal diseases. Aspartate Aminotransferase (AST): Certain types of liver and heart diseases. Alanine Aminotransferase (ALT): Certain liver (e.g., viral hepatitis and cirrhosis) and heart diseases.

Source page: https://510kreport.com/device/K251074
Methodology: https://510kreport.com/methodology