(135 days)
The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The LipidPro® Lipid Profile and Glucose Measuring System is intended to be used by a single patient and should not be shared.
The LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, LipidPro® Lipid Profile Test Strip, and LipidPro® Glucose Test Strip are for use with the LipidPro® Lipid Profile and Glucose Meter.
The LipidPro® Total Cholesterol Test Strip and the LipidPro® HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Total Cholesterol Test Strip and LipidPro® HDLcholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole bloodandthe obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are ≤ 350 mg/dL; when triglycerides are > 350 mg/dL. calculated LDL-cholesterol are not reported. The LipidPro® Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Glucose Test Strip is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand. upper arm, forearm, caff and/or thigh by diabetic patients as an aid in the management of diabetes, Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
LipidPro® Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Lipid Profile and Glucose Measuring System and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only). LipidPro® Control Solutions are intended for use in home.
The LipidPro® Professional Lipid Profile and Glucose Measuring Systemis intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Lipid Profile and Glucose Measuring System which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), and glucose in capillary whole blood. The LipidPro® Professional Lipid Profile and Glucose Measuring System should only be used with auto-disabling, single-use lancing device.
The LipidPro® Professional Total Cholesterol Test Strip, LipidPro® Professional HDL-cholesterol Test Strip, LipidPro® Professional Triglyceride Test Strip, LipidPro® Professional Lipid Profile Test Strip, and LipidPro® Professional Glucose Test Strip are for use with the LipidPro® Professional Lipid Profile and Glucose Meter.
The LipidPro® Professional Total Cholesterol Test strip and the LipidPro® Professional HDLcholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Professional Total Cholesterol Test strip and ' LipidPro® Professional HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Professional Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are ≤ 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDLcholesterol are not reported.
The LipidPro® Professional Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Professional Glucose Test Strip is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
The LipidPro® Professional Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Professional Lipid Profile and Glucose Measuring System and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings.
The LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System consist of a meter, test strips, and control solutions. It combines measuring systems for total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and a blood glucose monitoring system into one convenient device.
The components are a meter, five types of test strips, and four types of control solutions. There are five types of the test strips which are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), a lipid profile (which combines TC, HDL-C, and TG tests) and glucose test respectively. There are also four types of the control solutions for total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose test respectively.
This appears to be a 510(k) summary for the Infopia LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System. This document outlines the device's intended use, comparison to a predicate device, and a general statement about performance data, but it does not contain detailed information about specific acceptance criteria and the comprehensive study results to prove those criteria were met in a table format.
The document generally states: "Clinical & Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the LipidPro® / LioidPro® Professional Lipid Profile and Glucose Measuring System. The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not elaborate on what those pre-determined Pass/Fail criteria were or present the specific performance metrics achieved.
Therefore, I cannot directly extract the requested information as it is not provided in the input text. The input document is a summary of the 510(k) submission, confirming that studies were performed and passed, but not detailing the acceptance criteria or the specific results.
To fulfill your request, I would need access to the full 510(k) submission, specifically the sections pertaining to "Performance Data" which would include the detailed clinical and non-clinical study reports.
§ 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.