(90 days)
DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm,). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.
The DA01 Blood Glucose Test Strips are used with the DA01 Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.
The DiaLife mini is a PC-based software intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The DiaLife mini software receives via USB, stores, and uses patient data for display and reporting. It is intended for use as an accessory to DELBio DA01 Blood Glucose Monitoring System.
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The provided text describes a medical device named the "DA01 Blood Glucose Monitoring System" and its regulatory clearance. However, it does not contain the detailed acceptance criteria and the study results as requested by the user.
The document is a 510(k) clearance letter from the FDA, indicating market clearance for the device based on substantial equivalence to existing predicate devices. It outlines the intended use, regulatory classification, and general information about FDA regulations. It does not include specific performance studies or acceptance criteria beyond stating that the device is for "quantitative measurement of glucose level."
Therefore, I cannot provide the requested information based on the given input.
§ 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.