(119 days)
microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Blood Glucose Meter The microdot Blood Glucose Meter is intended for the quantitative measurement r fromlers in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Test Strips The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by o grassowith diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Control solutions miorodot oontrol solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.
The microdot® Blood Glucose System is comprised of the microdot® Meter, Test Strips, & three controls. The test strip is inserted into the device, a drop of blood is added to the strip, and a glucose result is presented in 10 seconds.
The test principle is based on electrochemical biosensor technology. Glucose dehydrogenase converts to glucose to gluconolactone, with reduction of NAD to NADH. Re-oxidation of the mediator by the meter induces a micro current to flow, and the size of the micro current is directly proportional to the amount of glucose in the blood. The micro current is detected in of the blood glucose concentration.
The provided document describes the microdot® Blood Glucose Monitoring System and its performance studies. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for accuracy in the same way modern regulatory submissions do (e.g., ISO 15197:2013). However, it reports on several performance metrics that demonstrate its equivalence to a predicate device and its overall functionality. Given the context of the comparison to the predicate device and the non-clinical and clinical study results, the implied acceptance criterion for accuracy is a strong correlation with a reference method and acceptable bias within a specified hematocrit range.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical Study) | Strong correlation with YSI reference method and similar performance to predicate device. | Regression equation for microdot® vs. YSI: y = 1.0055x + 0.7776, r = 0.982 (when tests carried out by healthcare professionals). |
| Predicate (One Touch® Ultra™) vs. YSI: y = 0.9705x - 1.3727, r = 0.988. | ||
| Linearity | High correlation coefficient (r > 0.99) across the measuring range. | Venous blood spiked with glucose (20 to 520 mg/dL): |
- Lot 1: slope = 0.93, r = 0.996
- Lot 2: slope = 0.94, r = 0.996 |
| Precision (Within-run CV%) | Low coefficient of variation (CV%) at various glucose concentrations. Specific criteria not defined, but generally
§ 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.