# K181373: Extended Lipid Panel Assay

- Pathway: 510(k) (Traditional)
- Applicant: Laboratory Corporation of America Holdings
- Decided: Oct 18, 2018 after 147 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: 3 generations back to K023158 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012286: Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation, Roche Diagnostics Corp. (2001) Summary page 4.
- K031824: Cobas Integra Cholesterol Gen. 2, Roche Diagnostics Corp. (2003) Summary page 4.
- K873049: Triglycerides Gpo Without Free Glycerol, Boehringer Mannheim Corp. (1987) Summary page 4.
- K063608: Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High, Dade Behring, Inc. (2007) Summary page 4.

## Indications for use
The Extended Lipid Panel Assay is an in vitro diagnostic test for quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human serum and plasma, and Apolipoprotein B in human serum. Values for Total Cholesterol, High Density Lipoprotein Cholesterol, Triglycerides and Apolipoprotein B are calculated by the Vantera® Clinical Analyzer. • Total Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders. • High Density Lipoprotein Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. • Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. • Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

Source page: https://510kreport.com/device/K181373
Methodology: https://510kreport.com/methodology