# K223179: Cholestech LDX ™ System

- Pathway: 510(k) (Dual Track)
- Applicant: Alere San Diego, Inc.
- Decided: Sep 20, 2023 after 344 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K120615 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120615: Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu Cassette, Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen (2013) Summary page 6.

## Indications for use
The Cholestech LDX™ System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes: The Lipid Profile•GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported. The TC•HDL•GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood. The TC•GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood. The Lipid Profile cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported. The TC•HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood. The TC cassette is for the quantitative determination of total cholesterol in whole blood. • Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. • HDL (lipoprotein) 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. • Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K223179
Methodology: https://510kreport.com/methodology