(284 days)
GoChek Blood Glucose Monitoring System
The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Connect Blood Glucose Monitoring System
The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Blood Glucose Monitoring System and GoChek Connect Blood Glucose Monitoring System (also called "GoCheck series") perform quantitative assays of glucose in fresh capillary whole blood obtained from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
Both the systems share the same GoChek Blood Glucose test strips. It has a reagent system in test window that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample. This reaction, in turn produces an electrical current that is measured by the meter's electronics through test strip contact area. The meter, then calculates and displays the blood glucose concentration reading, calibrated to a plasma reference.
GoChek Connect Blood Glucose Monitoring System has Bluetooth and serial interfaces that comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. This Bluetooth function will allow user to transfer their test results from BG meter to a specific app which developed by MicroTech. Users can choose to utilize these function by following the instruction to set it up, otherwise these functions will remain shut off.
Here's an analysis of the acceptance criteria and study findings for the GoChek Blood Glucose Monitoring System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are derived from the "FDA Guidance for Industry and Food and Drug Administration Staff Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, October 2016." The study reported results indicating the device meets these criteria.
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance (GoChek Series) |
|---|---|
| 95% of results within +/- 15% of comparator | 95% of all SMBG results are within +/- 15% of the comparator results |
| 99% of results within +/- 20% of comparator | 99% of all SMBG results are within +/- 20% of the comparator results |
Note: The reported performance is stated to be "across the entire claimed measuring range of the device," which is 10-580 mg/dL.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Method Comparison/User Evaluation were conducted with lay persons (including naïve and non-naïve SMBG users) using the GoChek series." However, it does not specify the exact sample size of lay persons or the number of blood samples collected for the primary method comparison/user evaluation.
For the laboratory setting study conducted for extreme glucose concentrations, the document also does not specify the sample size used, only that "studies using blood samples in the extreme upper and lower ends of the claimed measuring range (10 to 580 mg/dL) altered to achieve glucose concentrations of less than 80 mg/dL and greater than 250 mg/dL was performed."
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is MicrotechMedical (Hangzhou) Co., Ltd in China. The studies are described as "non-clinical tests" and "method comparison/user evaluation," implying prospective data collection during the development and validation phase of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document states the comparator used for determining ground truth was the YSI Model 2300 STAT PLUS. This is a laboratory reference instrument, not human experts. Therefore, no information is provided about the number or qualifications of experts for establishing ground truth from this source.
4. Adjudication Method for the Test Set
No adjudication method is mentioned because the ground truth was established by a reference laboratory instrument (YSI Model 2300 STAT PLUS), not through expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a Blood Glucose Monitoring System, which does not involve human readers interpreting images or data in a comparative effectiveness study with and without AI assistance in the way clinical imaging devices might. The user evaluation involves lay persons operating the device, but it's not described as an MRMC study to compare human interpretation with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was clearly done. The "Method Comparison/User Evaluation" and the "studies using blood samples in the extreme upper and lower ends of the claimed measuring range" directly assessed the GoChek series (the algorithm and device) itself against a reference method (YSI Model 2300 STAT PLUS) to determine its accuracy. This is a direct measure of the device's inherent performance.
7. Type of Ground Truth Used
The ground truth used was reference laboratory measurement from the YSI Model 2300 STAT PLUS.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This is common for predicate-based 510(k) submissions for devices like blood glucose meters, where the focus is on validation rather than demonstrating the performance of a machine learning algorithm that requires a distinct training phase. These devices are typically developed using established electrochemical principles rather than AI/ML techniques requiring large training datasets.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the context of AI/ML, there is no information on how its ground truth was established. The device likely relies on a fixed algorithm based on the FAD-GDH enzyme and amperometric detection method described, rather than a machine learning model that needs to be "trained."
§ 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.