(29 days)
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 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 mellius, 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 includes the CardioChek Plus professional analyzer and analyte-specific test strips (PTS Panels eGLU test strips, PTS Panels Glucose test strips and PTS Panels Lipid Panel test strips). The CardioChek Plus Test System is modified in this submission by the addition of the CardioChek ChekMate strips. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.
The provided text describes the CardioChek Plus Test System and its modification with the addition of CardioChek ChekMate strips. The 510(k) summary focuses on the performance characteristics of these new ChekMate strips, particularly their precision and stability.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria in a dedicated table format. However, it reports on the precision of the CardioChek ChekMate strips.
| Performance Characteristic | Acceptance Criteria (Implicit from Results) | Reported Device Performance (CardioChek ChekMate Strips) |
|---|---|---|
| Intermediate Precision (% CV) |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.