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The iGlucose 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 fingertips. The iGlucose Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The iGlucose Blood Glucose Monitoring System 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 iGlucose Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

The iGlucose Blood Glucose Test Strips are for use with the iGlucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The iGlucose Blood Glucose Monitoring System consists of the iGlucose meter, the iGlucose test strips and the Rightest Glucose Control Solutions (GC550 level 2 and 4 (previously cleared under K092052). Bionime is seeking FDA's clearance to market and commercially distribute in the United States the iGlucose Meter and its corresponding iGlucose Test Strips.

The iGlucose meter is an electronic device that utilizes electrical characteristics technology. When used with its corresponding iGlucose Test Strips, it quantitatively measures glucose in a small drop of fresh capillary whole blood (minimum 0.75 µL). The blood drop is placed on the test strip where it interacts with reagents in the presence of glucose oxidase to produce an electrical current proportional to the amount of glucose in the sample. The oxidase electrochemical sensor of the meter measures the current and using meter software converts it to the corresponding glucose concentration. The glucose result is then displayed on the meter within 5 seconds.

Other system components include:

• Rightest lancing device labeled for "Single Patient Use only" as well as its . disposable sterile lancets.
• Meter charger and cable
• A clear cap for the lancing device

Here's a breakdown of the acceptance criteria and study information for the iGlucose Blood Glucose Monitoring System, extracted from the provided FDA 510(k) summary:

iGlucose Blood Glucose Monitoring System: Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The document states that the iGlucose meter's performance falls within acceptance criteria, and specific metrics are provided from a lay-user trial comparing the iGlucose to a reference method (YSI 2300 Plus).

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