(270 days)
The GlucoPack™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. GlucoPack™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertips only.
The GlucoPack Diabetes Monitoring System is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.
The GlucoPack™ Meter device is used along with the GlucoPack™ Test Strip to measure the glucose level in whole blood.
The provided document describes the GlucoPack™ Blood Glucose Test System (K052469) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.
This 510(k) summary focuses on general device description, intended use, and comparison to predicate devices for substantial equivalence determination. Performance data, if present in the original submission, is not included in this extract.
Therefore, I cannot provide the requested information based on the given input. The requested details typically reside in the performance data section of a 510(k) submission, which is absent here.
§ 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.