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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:

Without the actual numerical performance data and specific ISO 15197:2003 criteria, a detailed table cannot be populated.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for the Test Set: Not explicitly stated in the provided text. The document mentions "clinical tests" were performed, but does not specify the number of blood samples or participants involved.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the clinical tests were performed by "professionals."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not provide any information about the number of experts used or their qualifications to establish ground truth. For blood glucose monitoring systems, ground truth is typically established by comparing results to a laboratory reference method (e.g., YSI analyzer), rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set:

• The document does not mention any adjudication method for the test set. Given that this is a blood glucose monitoring system, the "ground truth" would usually be established by a laboratory reference method, implying a direct comparison rather than a separate adjudication process by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The FIA Blood Glucose Monitoring System (G2) is an in vitro diagnostic device for self-testing blood glucose, where the output is a numerical value directly from the device, not an interpretation by a human reader. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

• Yes, in spirit, the primary performance evaluation described is standalone. The device itself (meter and test strip) is designed to provide a direct quantitative measurement of glucose. The "clinical tests" performed against ISO 15197:2003 evaluate the accuracy of the device's measurements relative to a reference method, which is essentially its standalone performance. There isn't a "human-in-the-loop" component in the sense of a human interpreting the device's output and then having that interpretation evaluated.

7. Type of Ground Truth Used:

• The document implies that the ground truth for the clinical tests was based on a reference method to which the device's measurements were compared, aligning with the requirements of ISO 15197:2003. For blood glucose monitors, this is typically a laboratory reference method (such as a YSI glucose analyzer) that provides highly accurate glucose concentration values. The text doesn't explicitly name the reference method, but states compliance with a standard designed for such comparisons.

8. Sample Size for the Training Set:

• The document does not provide any information about a training set size. For a blood glucose monitoring system, the "training set" would refer to data used for the initial development and calibration of the device's algorithm, which is typically an internal process and not usually detailed in a 510(k) summary in this manner. The focus here is on the verification and validation of the final product.

9. How the Ground Truth for the Training Set Was Established:

• The document does not provide any information on how the ground truth for a training set (if one was formally defined for algorithm development) was established. As mentioned above, for this type of device, it would generally involve comparison to a laboratory reference method.

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