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The 3test® Glucose Supreme Monitoring System 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, 3test* Supreme Glucose Monitoring System only needs a small amount of blood ( 2μL. same as predicate device ). 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 5 seconds, and 200 blood glucose result memory.

The provided text is a 510(k) summary for the "3test® Supreme Glucose Monitoring System." It states that the device is substantially equivalent to a predicate device (3test® Blood Glucose Monitoring System, K050224) and describes its intended use and basic technology. However, it does not include detailed acceptance criteria, specific performance metrics, or information about a comprehensive study that proves the device meets those criteria. The document focuses on regulatory approval based on equivalence rather than presenting an in-depth performance study with acceptance criteria and results.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Details for 3test® Supreme Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not specify any quantitative acceptance criteria or report specific performance metrics for accuracy, precision, linearity, or other analytical performance characteristics. It relies on the claim of substantial equivalence to a predicate device (K050224) which is stated to have the "same working principle and technologies."

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

• Sample Size for Test Set: Not provided.
• Data Provenance: The document mentions "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; Guidance for Industry and FDA document provided by CDRH/ FDA." However, it does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

• Not provided. The document does not describe the methodology for establishing ground truth for any test set.

4. Adjudication Method for the Test Set:

• Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a MRMC comparative effectiveness study is not mentioned as this is a glucose monitoring system, not an imaging device typically assessed with MRMC studies.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not applicable in the typical sense for a glucose monitoring system. This device is used by individuals (patients or healthcare professionals) to obtain a reading. The performance relates to the accuracy of the sensor and meter, not an AI algorithm.

7. The Type of Ground Truth Used:

• Not explicitly stated. For glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) to measure glucose levels in the same blood samples used for device testing. The document refers to "Pre-clinical and clinical data" but does not detail how ground truth was established for those studies.

8. The Sample Size for the Training Set:

• Not applicable as this is a glucose monitoring system that uses electrochemical biosensor technology, not a machine learning or AI-based device that would typically have a "training set."

9. How the Ground Truth for the Training Set was established:

• Not applicable for the same reason as above.

Summary of Device and Approval Basis:

The "3test® Supreme Glucose Monitoring System" uses an electrochemical biosensor and capillary action to measure glucose in whole blood. It requires 2μL of blood and provides results in 5 seconds. The device is intended for self-monitoring by people with diabetes at home and for use by healthcare professionals in clinical settings.

The 510(k) clearance (K072905) for this device was based on a claim of substantial equivalence to the predicate device, the "3test® Blood Glucose Monitoring System" (K050224). The manufacturer states that both devices use the "same test strips, have the same working principle and technologies." The differences noted are in the levels range of the control solution, battery number, memory results, and test strip lot calibration, which were deemed to not raise new safety or effectiveness aspects. The provided document details the regulatory approval process but does not contain the specific performance study data or acceptance criteria that would typically be reported in a technical validation study.

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