(87 days)
The Easy Step / DIACHEX PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro . diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. Easy Step / DIACHEX* PRO provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 5 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
This submission pertains to the Easy Step / DIACHEX* PRO Blood Glucose Monitoring System.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are based on the ISO 15197 standard for clinical accuracy.
| Acceptance Criteria (ISO 15197) | Reported Device Performance (Easy Step) | Reported Device Performance (DIACHEX* PRO) | Reported Device Performance (DIACHEX* INFINITY - Predicate) |
|---|---|---|---|
| 95% of individual glucose results falling within ±15 mg/dL at glucose concentration for samples 0.96) for all proposed and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Accuracy (Primary Test Set):
- Sample Size: 129 participants for fingertip testing. 113 participants for alternate site testing (palm and forearm).
- Data Provenance: The study was an "in-house study" performed by technicians, implying it was conducted by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer being in Taiwan. The study appears to be prospective, as it involved collecting samples from participants specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established using a YSI glucose analyzer (likely a YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar laboratory reference method). There is no mention of experts (e.g., radiologists, pathologists) being used to establish the ground truth for this type of glucose monitoring device. The YSI system itself serves as the reference standard.
4. Adjudication Method for the Test Set
Not applicable. For blood glucose monitoring systems, the ground truth is typically a direct measurement from a highly accurate laboratory reference instrument (like the YSI analyzer), rather than a subjective assessment requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not presented. This type of study is usually conducted for imaging devices where human readers interpret results, and the AI's impact on human performance is evaluated. For blood glucose meters, the performance is assessed against a laboratory reference.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was primarily conducted. The "Performance Characteristic Summary" section details the device's accuracy (precision, linearity, clinical accuracy) directly compared to the YSI reference method. The "clinical accuracy" study involved technicians taking readings, but the core evaluation is of the device's measurement against a golden standard.
7. Type of Ground Truth Used
The type of ground truth used was laboratory reference method data, specifically results obtained from a YSI glucose analyzer. This is considered the "gold standard" for glucose measurement in many clinical and research settings.
8. Sample Size for the Training Set
The document does not provide a specific sample size for a "training set." The submission describes performance characteristics of the finalized device. For IVD devices like blood glucose meters, the development process involves internal calibration and validation steps, but a distinct "training set" in the context of machine learning is not typically disclosed in 510(k) summaries, nor is it always applicable in the same way it would be for complex AI algorithms in image analysis.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, information on a distinct "training set" is not provided. For the initial calibration and development of such a device, similar laboratory reference methods (e.g., YSI) would be used to establish the correct response for different glucose concentrations. The chemical formula and enzyme used in the test strip are identical to a previously cleared device (K062829), suggesting that the fundamental detection mechanism, which would have been rigorously characterized, remains unchanged.
§ 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.