LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251157

    Validate with FDA (Live)

    Device Name
    Core Metabolic
    Manufacturer
    Truvian Health
    Date Cleared
    2026-01-09

    (269 days)

    Product Code
    CIX,CEK,CFR
    Regulation Number
    862.1035
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    18 - 120
    Reference & Predicate Devices
    K950164,K200898
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K950164

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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.
    Device Description

    The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the TruVerus™ and the TruWellness Panel™, a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.

    The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the TruVerus™, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards at the end of the run.

    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 intended for in vitro quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood samples.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1