(20 days)
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels for better glucose control among diabetics.
The DIACHEX Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, are adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. DIACHEX device provides a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter to quantitatively measure glucose in capillary whole blood obtained from the fingertip. When the edge of the DIACHEX 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 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The DIACHEX Test Strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
Here's an analysis of the provided text regarding the DIACHEX Blood Glucose Monitoring System, focusing on acceptance criteria and supporting studies:
Summary of Acceptance Criteria and Study Findings for DIACHEX Blood Glucose Monitoring System (K062829)
Based on the provided 510(k) Summary for K062829, the DIACHEX Blood Glucose Monitoring System is presented as substantially equivalent to the EZ Smart-168 Blood Glucose Monitoring System (K052818). The core of the justification for substantial equivalence lies in the established performance characteristics of the predicate device and the assertion that the changes in the DIACHEX device do not impact safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state separate "acceptance criteria" for the DIACHEX device against which a new study's results are presented. Instead, it relies on the predicate device's established performance and asserts that the DIACHEX device maintains these through direct comparison and evaluation of specific parameters. The table below compiles the performance parameters mentioned and the implied "reported performance" for DIACHEX, which is stated as being "the same" or "similar" to the predicate.
| Feature/Performance Parameter | Predicate Device (EZ Smart-168) (K052818) | Proposed Device (DIACHEX) | Acceptance Criteria (Implied) | DIACHEX Reported Performance (Claimed) |
|---|---|---|---|---|
| Intended Use | Measure glucose in capillary whole blood from fingertip for home/professional settings. | Same | Equivalent to predicate | Same as predicate |
| Test Principle | Electrochemical biosensor with glucose oxidase. | Same | Equivalent to predicate | Same as predicate |
| Specimen Type | Capillary whole blood from fingertip | Same | Equivalent to predicate | Same as predicate |
| Sample Volume | Around 1.5 µL | Same | Equivalent to predicate | Same as predicate |
| Measuring Time | 10 seconds | Same | Equivalent to predicate | Same as predicate |
| Detecting Range (Glucose) | 20 ~ 600 mg/dL | Same | Equivalent to predicate | Same as predicate |
| HCT Range | 35 ~ 55 % | Same | Equivalent to predicate | Same as predicate |
| Operating Temperature | 10 to 40 °C (50-104°F) | Same | Equivalent to predicate | Same as predicate |
| Strip Storage Temperature | 4 to 30 ℃ (40-86°F) | Same | Equivalent to predicate | Same as predicate |
| Battery Power | One 3 V Lithium CR 2032 battery | Same | Equivalent to predicate | Same as predicate |
| Meter Coding | Glucode Chip | Same | Equivalent to predicate | Same as predicate |
Changes from Predicate (and implied maintenance of performance):
| Item | Predicate Device | Proposed Device | Implied Impact on Performance |
|---|---|---|---|
| Test Strips size | 33.5 x 5 (mm) | 33.5 x 7 (mm) | Claimed no impact on performance |
| Average result | Only 28 tests average | 14-Day Average | Software feature, no impact on core measurement performance |
| Memory capacity | 28 Test Results | 300 Test Results | Software feature, no impact on core measurement performance |
| Button Design | One button | Two buttons | User interface, no impact on core measurement performance |
| PCB Size | 72 x 42 (mm) | 92 x 44 (mm) | Internal component size, claimed no impact on core measurement performance |
| Meter Dimension | 76 x 47 x 16 (mm) | 102 x 52 x 17 (mm) | Physical size, claimed no impact on core measurement performance |
| Meter Weight | 44 grams | 55 grams | Physical weight, claimed no impact on core measurement performance |
| LCD Display | 40 x 21.5 (mm) | 37.5 x 34 (mm) | Physical size, no impact on core measurement performance |
The core "acceptance criteria" here appear to be focused on maintaining equivalence to the predicate device across all critical performance parameters. The "reported device performance" is essentially that the DIACHEX device demonstrates this equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for the evaluations conducted on the DIACHEX system. It only states that "An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For blood glucose monitoring systems, "ground truth" often refers to reference methods (e.g., YSI glucose analyzer) rather than expert consensus on individual readings.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The DIACHEX Blood Glucose Monitoring System is a standalone diagnostic device for quantitative glucose measurement and does not involve human readers interpreting images or data where AI assistance would be relevant for improving reader performance. There is no AI component mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
Yes, a "standalone" evaluation was done in the sense that the device's inherent performance was assessed. The statement "An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity" describes performance testing of the device itself, without necessarily involving a human operator measuring their own performance alongside the device. The data presented essentially represents the algorithm/device's performance.
7. The Type of Ground Truth Used:
For blood glucose monitoring systems, the "ground truth" for evaluating accuracy is typically established using a laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated for the DIACHEX evaluation, the predicate device comparison implies that any performance evaluations would have used similar established laboratory methods as the gold standard, given that the DIACHEX "is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods" (stated in the device description and test principle).
8. The Sample Size for the Training Set:
This information is not provided and is largely irrelevant in the context of this device. The DIACHEX system is based on electrochemical biosensor technology, not a machine learning model that requires a distinct "training set." Its calibration is based on established chemical principles and comparison to reference methods, not iterative training data.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no "training set" in the context of a machine learning algorithm. The device's calibration and accuracy are established through its electrochemical design and validation against laboratory reference methods.
In conclusion:
The 510(k) submission for the DIACHEX Blood Glucose Monitoring System relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (EZ Smart-168 Blood Glucose Monitoring System K052818). The core argument is that fundamental scientific technology, operating principles, and critical performance parameters remain unchanged, despite minor physical and user interface modifications.
The provided document briefly mentions that an "evaluation" was conducted covering temperature effects, hematocrit levels, sensitivity, and linearity to demonstrate equivalence. However, it lacks specific details regarding the methodology of this evaluation, including sample sizes, data provenance, ground truth establishment methods, or detailed results, typically found in a full study report. The acceptance criteria are implicitly met by demonstrating that the new device's performance aligns with the established and accepted performance parameters of the predicate device.
§ 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.