(273 days)
The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile app.
The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results.
The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.
The provided text does not contain detailed information about a study proving the device meets acceptance criteria, specifically not in the format requested for a scientific study with sample sizes, expert qualifications, or comparative effectiveness.
However, based on the information provided, here's what can be inferred and presented, focusing on the acceptance criteria as stated in the context of substantial equivalence for a medical device (MDT2 BLE Self-Monitoring Blood Glucose System):
The document indicates that the MDT2 BLE Self-Monitoring Blood Glucose System is considered "substantially equivalent" to its predicate device, the EM40 Self-Monitoring Blood Glucose System (K133389). This implies that the acceptance criteria for the MDT2 BLE system are aligned with those previously met by the EM40 system, particularly since most core functionalities and technologies remain the same.
The modifications to the MDT2 BLE system are primarily related to its physical design, software features (memory mode, measurement mode, reset function, display icons), and the addition of Bluetooth functionality for wireless data transfer. These modifications were subjected to risk analysis and verified/validated.
Given the information, I can construct a table for what could be considered "acceptance criteria" based on the predicate device's performance, and then note that the new device states it meets these as part of its "substantial equivalence" claim.
Acceptance Criteria for MDT2 BLE Self-Monitoring Blood Glucose System and Reported Device Performance
| Feature/Metric | Acceptance Criteria (based on predicate EM40 SMBGS) | Reported Device Performance (MDT2 BLE SMBGS) |
|---|---|---|
| Intended Use | Quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. For in-vitro diagnostic use at home by a single patient with diabetes as an aid to monitor effectiveness of diabetes control. Not for neonates, diagnosis or screening for diabetes mellitus. Alternative site testing only during steady-state blood glucose conditions. | Same as predicate. The MDT2 BLE Self-Monitoring Blood Glucose System has the same intended use. |
| Sample Type | Fresh capillary whole blood | Same as predicate. |
| Sample Site | Finger, palm or forearm | Same as predicate. |
| Sample Volume | 0.6 µL | Same as predicate. |
| Reaction Time | 5 seconds | Same as predicate. |
| Measuring Range | 20-600 mg/dL | Same as predicate. |
| Hematocrit Range | 20-60% | Same as predicate. |
| Operating Condition | 10-40°C ( |
§ 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.