# K151545: CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System - Pathway: 510(k) (Traditional) - Applicant: Polymer Technology Systems, Inc. - Decided: Dec 22, 2016 after 562 days - Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol) - Device class: 1 - Regulation: 21 CFR 862.1175 - 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: 5 generations back to K870012 (1987). 16 ancestors in all. No later device cites it as a predicate yet. 0 of 17 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 10. - K023558: PTS Panels Lipid Panel Test Strips, Polymer Technology Systems, Inc. (2002) Summary page 10. ## Recalls of this device - Jun 7, 2019 · Class III · Z-2157-2019: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 - Jun 7, 2019 · Class III · Z-2158-2019: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 ## Indications for use The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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. 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. A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Home Analyzer. The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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. 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. A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer. The CardioChek PA Test System (consisting of the CardioChek PA analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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. 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. A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Analyzer. The CardioChek PA Home Test System (consisting of the CardioChek PA Home analyzer and CardioChek Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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. 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. A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Home Analyzer. Source page: https://510kreport.com/device/K151545 Methodology: https://510kreport.com/methodology