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

The eBchek 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 eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBchek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired.

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

eB-series Control Solutions are for use with the eBchek Blood Glucose Meter and eBchek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Based on an electrochemical biosensor technology and the principle of capillary action, eBchek Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed on the meter. This system contains some speaking functions, but is not intended for use by the visually impaired.

The eBchek Blood Glucose Monitoring System consists of the eBchek Meter, eBchek test strips with instruction, lancing device, lancets, code card, two AAA Batteries, users manual, carrying case. eB-series control solutions (previously cleared in K062555 as eBsensor control solution) with two different glucose concentration ranges (Level 1 and Level 2) are available but sold separately.

The original text describes a medical device, the eBchek Blood Glucose Monitoring System, and its performance studies. However, the document does not include detailed acceptance criteria or a comprehensive study report with specific data provenance, sample sizes for test and training sets, expert qualifications, or adjudication methods in the way typically expected for AI/ML device descriptions.

The document states that the Performance Studies are "based on ISO 15197: In vitro diagnostic test systems- Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus." It concludes that "Performance on the eBchek Blood Glucose Monitoring System demonstrated that the device meets the requirements for its intended use" and "replicates the predicate device."

Without the full ISO 15197 study report, I cannot provide all the requested details. However, I can infer some information based on typical requirements for blood glucose monitoring systems and the provided text.

Based on the provided information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems generally follow ISO 15197. While the specific ISO 15197 table is not provided, the general performance criteria for accuracy typically involve comparing the device's readings to a laboratory reference method. The document states that the device "meets the requirements for its intended use" and "demonstrated that the device is substantially equivalent to the predicate."

A typical summary of accuracy for a blood glucose monitor under ISO 15197 would involve percentage of results within certain deviation ranges from a reference method. For self-testing devices, common accuracy criteria at the time this submission was made were:

• **For glucose concentrations

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