# K251157: Core Metabolic

- Pathway: 510(k) (Traditional)
- Applicant: Truvian Health
- Decided: Jan 9, 2026 after 269 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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 K924964 (1992). 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)
- K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin, Medicon Hellas S.A (2021) Summary page 6.
- K950164: Piccolo (TM) Primary Health Panel Reagent Rotor, Abaxis, Inc. (1995) Summary page 6.

## Indications for use
The Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in the diagnosis and treatment of the following disorders in adults 18 years of age or older: - Glucose (GLU): Carbohydrate metabolism disorders, including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. - Total Protein (TP): Variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders. - Albumin (ALB): Numerous diseases involving primarily the liver and kidneys.

Source page: https://510kreport.com/device/K251157
Methodology: https://510kreport.com/methodology