(175 days)
The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.
The SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer and quality control materials and may include data transfer or management hardware and/or software tools.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested table and detailed information based on this input.
The document is a 510(k) summary and approval letter for the LifeScan SURESTEP Blood Glucose Monitoring System, primarily focusing on its substantial equivalence to previously marketed devices and its intended use. There is no mention of performance studies or acceptance criteria within 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.