# K162282: CardioChek Plus Test System, CardioChek Home Test System - Pathway: 510(k) (Special) - Applicant: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics - Decided: Dec 22, 2016 after 129 days - Product code: CGA (Glucose Oxidase, Glucose) - Device class: 2 - Regulation: 21 CFR 862.1345 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K980731 (1998). 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) - K071507: PTS Panels Chol+HDL+Glu Panel Test Strips, Polymer Technology Systems, Inc. (2007) Summary page 13. - K071593: PTS Panels Chol+HDL Panel Test Strips, Polymer Technology Systems, Inc. (2007) Summary page 13. - K041750: PTS Panels Chol+Glu Test Panel, Polymer Technology Systems, Inc. (2004) Summary page 13. ## Recalls of this device - Aug 16, 2022 · Class III · Z-1741-2022: Incorrect instructions for use were packaged into the final product. - Mar 15, 2016 · Class II · Z-0741-2020: This lot of test strips is showing an under-recovery when tested against a reference method. ## Indications for use The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. 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. 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. A Chol/HDL ratio is calculated by the CardioChek Home analyzer. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is 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. 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. 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. A Chol/HDL ratio is calculated by the CardioChek Plus analyzer. The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. 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. A Chol/HDL ratio is calculated by the CardioChek Home analyzer. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in venous whole blood and capillary whole blood from the fingertip and is 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. 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. A Chol/HDL ratio is calculated by the CardioChek Plus analyzer. The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism 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 (consisting of the CardioChek Plus analyzer and PTS Panels Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is 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. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism 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/K162282 Methodology: https://510kreport.com/methodology