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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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The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Based on an electrochemical biosensor technology and the principle of capillary action, eBcarryon 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 your blood glucose result is precisely and displayed in 10 seconds.

The provided document focuses on the eBcarryon Blood Glucose Monitoring System and its 510(k) submission (K091765). The summary of the device, its intended use, and the declaration of substantial equivalence to a predicate device are included. However, the document does not contain the specific details about acceptance criteria, device performance results, study design, or ground truth establishment that you've requested.

This document is a regulatory submission for premarket notification, primarily asserting substantial equivalence to a previously cleared device (eBsensor Blood Glucose Monitoring System, K062555). It outlines general information about the device and its intended use but lacks the detailed performance study information.

Therefore, I cannot provide the requested information from the given text. A typical 510(k) submission might include a detailed section on performance data to support claims, but that specific content is not present in the provided snippets.

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The eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Based on an electrochemical biosensor technology and the principle of capillary action, eBsensor Blood Glucose Monitoring System, eB-G only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.

The Visgeneer eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

Here's an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a detailed performance table from a study beyond referring to compliance with "Guidance Document for In Vitro Diagnostic Test System." Therefore, a definitive table of acceptance criteria and reported performance cannot be generated directly from the given text.

However, the document states that "A claim of substantial equivalence is made to LIFESCAN, INC. - One Touch Ultra Blood Glucose Monitoring System (K043197)." This implies that the eBsensor system's performance is expected to be comparable to or within acceptable limits of the predicate device.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical data (test set). It only mentions that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. For blood glucose meters, adjudication of expert opinions is not typically relevant as the ground truth is established by a more precise laboratory method.

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

No information is provided about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor is there any mention of human readers improving with or without AI assistance. This type of study is not typically relevant for a blood glucose monitoring system, which measures a quantitative biomarker directly.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The eBsensor system is a standalone diagnostic device. The performance data would inherently be "algorithm only" as it provides a direct measurement from a blood sample. The document does not detail the specific standalone performance study, but the substantial equivalence claim implies that its standalone performance meets regulatory expectations compared to the predicate device.

7. Type of Ground Truth Used

The type of ground truth used would almost certainly be a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer or a similar highly accurate clinical chemistry instrument). This is standard practice for validating blood glucose monitoring systems. The document does not explicitly state the method, but it is implied by the nature of the device.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is typical for a device using an electrochemical biosensor. While the sensor and algorithm would have been developed and calibrated with various samples, the 510(k) summary focuses on the validation of the final product with clinical data, usually referred to as the "test set" in this context even if not explicitly named.

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

As no training set is described in the document, there is no information on how its ground truth was established. If there were calibration or development data, the ground truth would also have been established using a laboratory reference method.

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