(66 days)
The On Call® Express II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly).
The On Call® Express II Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call® Express II Blood Glucose Monitoring System is not intended for the diamosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Express II Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
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This document is a 510(k) summary for the On Call® Express II Blood Glucose Monitoring System, which primarily describes the device and its indications for use, but does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory clearance letter, not a full study report or technical specification.
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§ 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.