(28 days)
PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. 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.
Dry chemistry test strip for use with PTS reflectance photometer. Single test strip with three tests.
The provided text does not contain detailed acceptance criteria or a study that explicitly demonstrates the device meets such criteria. It primarily focuses on the 510(k) summary for a modified medical device, comparing it to predicate devices. The document states "Similarities Between Predicate and Modified Device" and "Differences Between Predicate and Modified Device," but these refer to the device's characteristics and intended use, not performance metrics against acceptance criteria.
The submission is for a device modification, and the FDA has determined it to be "substantially equivalent" to legally marketed predicate devices, which implies that its performance is considered acceptable based on the already approved predicates. However, the specific performance data or acceptance criteria used for this determination are not detailed in the provided sections.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement as this information is not present in the provided text.
§ 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.