# K251091: Lipids

- Pathway: 510(k) (Traditional)
- Applicant: Truvian Health
- Decided: Dec 30, 2025 after 264 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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 K802743 (1980). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023642: Piccolo Total Cholesterol Test System, Abaxis, Inc. (2003) Summary page 5.
- K023639: Piccolo Triglycerides Test System, Abaxis, Inc. (2003) Summary page 5.

## Indications for use
Lipids is part of the TruWellness Panel™ and is intended for use on the TruVerus™. Lipids (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Total Cholesterol (TChol) and Triglycerides (TRIG) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the TRIG determination, Very Low-Density Lipoprotein Cholesterol (VLDL) is calculated by the analyzer. Lipids (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: Total Cholesterol (TChol): Excess cholesterol in the blood and lipid and lipoprotein disorders. Triglyceride (TRIG): Diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism; various endocrine disorders.

Source page: https://510kreport.com/device/K251091
Methodology: https://510kreport.com/methodology