(77 days)
The GLUCOLAB™ 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., including physician's office laboratories and point of care sites . The GLUCOLAB™ System provides plasma equivalent results. The GLUCOLAB™ System is not intended to be used with neonatal blood samples. The GLUCOLAB™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
The GLUCOLAB™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the GLUCOLAB™ 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.
Infopia, Co., Ltd. GLUCOLAB™ Blood Glucose Monitoring System Study Analysis
This analysis is based on the provided 510(k) summary for the Infopia, Co., Ltd. GLUCOLAB™ Blood Glucose Monitoring System.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages, error ranges). Instead, the document focuses on substantial equivalence to predicate devices. The implicit acceptance criterion is that the GLUCOLAB™ system performs comparably to the identified predicate devices: LifeScan, Inc., OneTouch® Ultra®, LifeScan, Inc. SURESTEP®, and Roche Diagnostics Corp. Accu-Chek Advantage.
The summary indicates that the GLUCOLAB™ Module is "substantially equivalent to the other products in commercial distribution intended for similar use." This is the reported device performance in relation to the acceptance criteria of substantial equivalence.
2. Sample Size and Data Provenance
The provided 510(k) summary does not contain information regarding:
- Sample size used for the test set.
- Data provenance (e.g., country of origin of the data, retrospective or prospective).
Without a detailed clinical study report, these crucial details cannot be extracted from the given text.
3. Number and Qualifications of Experts for Ground Truth
The provided 510(k) summary does not contain information regarding:
- Number of experts used to establish the ground truth for the test set.
- Qualifications of those experts.
For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not necessarily by human experts in the same way an imaging device might use radiologists. However, the document does not specify how the accuracy of the blood glucose readings was verified.
4. Adjudication Method
The provided 510(k) summary does not contain information regarding the adjudication method used for the test set. Given the nature of blood glucose testing, traditional adjudication methods like 2+1 or 3+1 concensus are unlikely to be directly applicable. Instead, the "ground truth" would be established by a gold standard laboratory method. However, the exact process is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is an in vitro diagnostic (IVD) device for quantitative measurement of glucose, and its performance is assessed through its direct measurement accuracy, not through human interpretation of complex data. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not relevant to this type of device.
6. Standalone Performance Study
Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was effectively done. For an in vitro diagnostic device like a blood glucose meter, the "standalone" performance refers to the accuracy of the device itself in measuring glucose levels. The 510(k) summary states that "The GLUCOLAB™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood..." and that "The test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. This reaction is measured by the Meter and displayed as your blood glucose result." This describes the direct, standalone operation of the device to produce a measurement.
While the document doesn't explicitly detail the study methodology to prove this standalone performance (e.g., through clinical trials comparing device readings to a laboratory standard), the entire 510(k) submission process for a blood glucose meter inherently requires demonstrating accurate performance of the device itself. The claim of "substantial equivalence" is based on the device's ability to produce similar accurate readings to the predicate devices.
7. Type of Ground Truth Used
The specific type of ground truth used to establish the accuracy of the GLUCOLAB™ system is not explicitly stated in the provided 510(k) summary. However, for blood glucose monitoring systems, the ground truth is typically established using laboratory reference methods (e.g., hexokinase method, glucose oxidase method) performed on blood samples. These methods are considered the "gold standard" for blood glucose measurement.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain information regarding the sample size for the training set. Blood glucose meters typically do not involve "training sets" in the same way machine learning AI models do. Their calibration and established performance are based on engineering design, chemical reactions, and manufacturing consistency, validated through clinical performance studies.
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" with associated ground truth is not typically applicable to a blood glucose meter in the context of an AI/machine learning model. The device operates based on a direct electrochemical principle. Therefore, there is no information provided on how ground truth for a training set was established because such a concept is not directly relevant to the described device and its underlying technology. The closest equivalent would be the manufacturing calibration process and subsequent validation against laboratory reference methods.
§ 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.