# K151530: CardioChek Plus Test System

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jul 7, 2015 after 29 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: 5 generations back to K870012 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System, Polymer Technology Systems, Inc. (2015) Summary page 5.

## Indications for use
The CardioChek Plus Test System is a small portable analyzer and test strip system intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. The tests strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer. • 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. • Triglycerides 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, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K151530
Methodology: https://510kreport.com/methodology