(133 days)
The Assure Platinum Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Assure Platinum Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Assure Platinum Blood Glucose Meter:
The Assure Platinum Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. 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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure Platinum Blood Glucose Test Strips:
Assure Platinum test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure Dose CONTROL:
For use with Assure Platinum Blood Glucose Meter and Assure Platinum Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Normal (Level 1) and High (Level 2).
The Assure Platinum Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
I am sorry, but I lack the ability to answer your request. The provided text is a 510(k) summary for a medical device (Assure Platinum Blood Glucose Monitoring System) and an FDA clearance letter. It describes the device, its intended use, and the fact that functional and safety testing (including clinical testing for accuracy) was performed to support its substantial equivalence to a predicate device. However, the text does not contain detailed information about the specific acceptance criteria for the clinical study, the reported device performance against those criteria, sample sizes used, data provenance, number or qualifications of experts, adjudication methods, or any information regarding MRMC studies, standalone performance, or training set details.
Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about the study design and results.
§ 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.