(232 days)
The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The BLE Smart Blood Glucose Test Strips are for use with the BLE Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly.
The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.
BLE Smart Blood Glucose Monitoring System / BLE Smart Professional Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BLE Smart Blood Glucose Monitoring System, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary (K160365) does not explicitly list quantitative acceptance criteria in a table format. However, it states that:
- "The device passed all of the tests based on pre-determined Pass/Fail criteria."
- "The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated [sic] device."
This implies that some performance metrics, likely related to glucose measurement accuracy, precision, and safety, were evaluated and met the pre-defined criteria. The predicate device (K130181, GluNEO™ Blood Glucose Monitoring System) would have had its own set of performance criteria, and the new device is deemed substantially equivalent.
For a blood glucose monitoring system, common performance metrics and their typical acceptance criteria (based on ISO 15197 or similar standards) would include:
| Acceptance Criteria Category | Typical Acceptance Criteria (e.g., ISO 15197) | Reported Device Performance (Implied) |
|---|---|---|
| Accuracy (System Accuracy) | For glucose concentrations |
§ 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.