# K140068: Cardiochek Plus Test System, Cardiochek Home Test System - Pathway: 510(k) (Special) - Applicant: Polymer Technology Systems, Inc. - Decided: May 22, 2015 after 494 days - Product code: NBW (System, Test, Blood Glucose, Over The Counter) - Device class: 2 - Regulation: 21 CFR 862.1345 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K870012 (1987). 11 ancestors in all. 6 later devices descend from it; 5 cite it directly. 0 of 18 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K014099: Bioscanner Plus, Polymer Technology Systems, Inc. (2001) Summary page 6. - K022898: PTS Panels Lipid Panel Test Strips, Polymer Technology Systems, Inc. (2002) Summary page 8. ## Most influential descendants - K163406: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (2017), 1 descendant of its own - K201037: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (2022), 0 descendants of its own - K193406: CardioChek Plus Test System; CardioChek Plus Home Test System (2022), 0 descendants of its own - K182781: PTS Professional Chemistry Kit (2018), 0 descendants of its own - K151545: CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (2016), 0 descendants of its own ## Recalls of this device - Dec 2, 2019 · Class II · Z-0833-2020: One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to - Dec 2, 2019 · Class II · Z-0835-2020: One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to - Dec 2, 2019 · Class II · Z-0832-2020: One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to - Dec 2, 2019 · Class II · Z-0834-2020: One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to ## Indications for use The CardioChek Home Test System is a small portable analyzer and test strip system for self-testing by lay users. It is intended to be used by a single person and should not be shared. 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 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. 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/K140068 Methodology: https://510kreport.com/methodology