(30 days)
Glucose Meter-Check" Control Solution is intended for in vitro diagnostic use to assess the performance of the Bayer Ascensia blood glucose test systems: Breeze 2, Contour, Elite and DEX 2 by healthcare professionals and in the home by people with diabetes mellitus.
Glucose Meter-Check" Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check" Control Solution is intended for use to verify the performance of Bayer Ascensia brand blood glucose test systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Glucose Meter-Check" Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.
Here's a breakdown of the acceptance criteria and study information for the Glucose Meter-Check™ Control Solution, based on the provided 510(k) summary:
This device is a control solution for blood glucose meters, not a diagnostic device that produces patient-specific measurements. Therefore, the acceptance criteria and study design are different from what would be expected for a diagnostic algorithm or imaging device. The "performance" being evaluated is the stability and consistent behavior of the control solution itself when tested on the specified blood glucose meters.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state formal "acceptance criteria" for the control solution in terms of specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the performance is demonstrated through comparison to predicate devices and verification tests, focusing on stability and consistent response within the expected range for a normal glucose level control.
| Aspect Tested | Reported Device Performance |
|---|---|
| Closed Bottle Stability | Tests were conducted to verify specific performance requirements. |
| Stability After Opening | Tests were conducted to verify specific performance requirements. |
| Test Mean Response Data | Tests were conducted to verify specific performance requirements. (Mean Assigned Value: 86 mg/dL on Ascensia Contour) |
| Precision Data | Tests were conducted to verify specific performance requirements. |
| Substantial Equivalence | Demonstrated through comparison of technological characteristics, formulation, and intended use to predicate devices. |
Note on "Acceptance Criteria": For control solutions, acceptance criteria typically relate to the stability of the analyte (glucose in this case) over time and under various storage conditions. The goal is for the control solution to consistently produce a reading on the target glucose meter that falls within a predefined acceptable range (often provided by the meter manufacturer). The summary states that tests were run to "verify specific performance requirements," implying these criteria were met, but the specific numerical targets for stability are not detailed in this public summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or algorithm performance. The "tests" mentioned are non-clinical studies on the control solution itself.
- Sample Size: Not applicable in the traditional sense of patient samples. The "samples" would be aliquots of the control solution tested on the blood glucose meters. The number of such tests or batches is not disclosed.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a non-clinical control solution study. These tests would have been performed by the manufacturer, Bionostics, Inc., likely in their facilities in Devens, MA, USA. They are prospective in the sense that they were designed to evaluate the product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
For a control solution, the "ground truth" for the declared glucose concentration is typically established by manufacturing specifications, internal quality control, and analytical methods (e.g., traceable reference methods) to determine the actual glucose concentration within the control solution. This is not typically done by "experts" reviewing patient data. The "ground truth" for the meter's performance is that it should read the control solution within an expected range.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
This type of study does not involve expert adjudication of results. The results are quantitative measurements of glucose on blood glucose meters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done.
MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. This device is a control solution for an in vitro diagnostic device (blood glucose meter), which is used to verify the meter's performance.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, in a way. The "device" being evaluated is the control solution itself. Its performance is entirely "standalone" in that it is evaluated for its inherent properties (stability, consistency) when used by the blood glucose meters per their instructions. There's no AI algorithm involved. The control solution itself doesn't have "human-in-the-loop" performance; it's a reagent.
7. The Type of Ground Truth Used
For the Glucose Meter-Check™ Control Solution:
- Type of Ground Truth: The "ground truth" for the control solution itself is its analytically determined glucose concentration (0.1% w/v glucose) and its stability. This would be established by the manufacturer using established analytical chemistry methods and Quality Control procedures, likely traceable to a primary reference standard. The "Mid Assigned Value" (e.g., 86 mg/dL for Ascensia Contour) serves as the expected reading for that specific meter.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable.
This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.