(233 days)
The EASYGLUCO™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. EASYGLUCO™ System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, palm, calf and thigh.
The EASYGLUCO™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
This 510(k) submission (K061431) for the EASYGLUCO™ G2 Blood Glucose Monitoring System provides a summary of the device and its intended use, but it does not contain the detailed study information or acceptance criteria you've requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It explicitly states in the "510(k) Summary" section: "According to the requirements of 21 CFR.807.92, the following information provides sufficient data to understand the basis for a determination of substantial equivalence." This means it's designed to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to present a full clinical study report with detailed performance metrics and acceptance criteria.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This level of detail is typically found in the full submission, not the summary.
- Sample size used for the test set and the data provenance: Not mentioned in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size: Not applicable for a blood glucose monitor, and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device, and not mentioned.
- The type of ground truth used: Not explicitly stated for performance evaluation, though for a blood glucose monitor, ground truth would typically be a laboratory reference method.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What the document does provide:
- Device Name: EASYGLUCO™ G2 Blood Glucose Monitoring System
- Predicate Device: LifeScan, Inc., OneTouch® Ultra® (K024194), LifeScan, Inc. SURESTEP® (K984261), Roche Diagnostics Corp. Accu-Chek Advantage (K021513)
- Device Description: An in vitro diagnostic device for measuring glucose in whole blood using a test strip with an electrochemical signal.
- Intended Use: Quantitative measurement of glucose in whole blood to monitor diabetes management in home and clinical settings, for in vitro diagnostic use only, not for neonatal blood specimens. Testing sites include fingertip and alternate sites (forearm, palm, calf, thigh).
To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to review the full 510(k) submission, which is much more extensive than the summary document provided here.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.