(406 days)
The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.
The GlucoLeader Enhance 2 Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide with testing. The GlucoLeader Enhance 2 Blood Glucose Monitoring System mainly consists of four parts as below,
- (1) GlucoLeader Enhance 2 Blood Glucose Meter
- GlucoLeader Enhance 2 Blood Glucose Test Strips* (2)
- Glucose Control Solutions (L1, L2)* (3)
- (4) Check Strip*.
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- These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.
Display screen size of the meter is 1.73" x 1.7", and weight of the meter is 0.122 lbs (55.2 grams). The GlucoLeader Enhance 2 Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing.
The GlucoLeader Enhance 2 Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.
If the GlucoLeader Enhance 2 Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.
The provided document is a 510(k) summary for the "GlucoLeader Enhance 2 Blood Glucose Monitoring System". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for the device's performance.
Specifically, it states: "No new clinical test data was used to support the decision of substantial equivalence." This means that the document does not contain the information requested regarding acceptance criteria and performance studies for the GlucoLeader Enhance 2 Blood Glucose Monitoring System itself. The changes in this new model (color, BLE module) were deemed not to affect the accuracy and effectiveness, thus relying on the predicate device's established performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample sizes, data provenance, expert involvement, ground truth establishment, or MRMC studies for this specific device.
If the information about acceptance criteria and performance studies for the predicate device (GlucoLeader Enhance Blood Glucose Monitoring System, K182448) were available, I would be able to answer some of these questions.
§ 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.