(511 days)
The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared.
The FlA Blood Glucose Monitoring System (G2) is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.
FIA Blood Glucose Monitoring System (G2) consists of:
(1) Glucose Meter
(2)Glucose Test Strips
(3)Two levels of glucose control solutions (L1 and L2) may be purchased separately. Glucose control solutions were previously cleared under K032985.
(4)Check Strip
(5)Instruction for use
FIA Blood Glucose Monitoring System (G2) is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
The FIA Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the FIA Blood Glucose monitoring system (G2) and FIA Blood Glucose Test strips (G2). There are two levels of controls (L1 and L2).
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance:
The document states that the FIA Blood Glucose Monitoring System (G2) is compliant with the standard ISO 15197:2003 In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. However, the exact numerical acceptance criteria from this standard and the specific reported device performance against those criteria are not explicitly detailed in the provided text.
The document only makes a general statement: "All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met."
To properly answer this section, one would typically expect a table like this:
| Performance Metric (from ISO 15197:2003) | Acceptance Criteria (from ISO 15197:2003) | Reported Device Performance (FIA BGMS G2) |
|---|---|---|
| For glucose concentration |
§ 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.