(30 days)
Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems:
- Bayer Contour Next blood glucose monitoring systems
- Bayer Breeze 2 blood glucose monitoring systems
- Bayer Contour and Contour TS blood glucose monitoring systems
Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Glucose Meter-Check Control Solution is a viscosity-adjusted, aqueous liquid glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. Glucose Meter-Check Control Solution is intended for use to verify the performance of the Bayer BGM systems listed in the package insert and is intended for use by healthcare professionals and people with diabetes mellitus at home. 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 Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Glucose Meter-Check® Solution for Bayer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| At least 95% of measurements obtained for the manufacturer-recommended quality control solution were within the value assignment ranges provided on the test strips for that meter, test strip, and control solution combination. | 100% of all values recovered within value assignment ranges provided with each vial of test strips for the manufacturer-recommended control solutions. |
| At least 95% of Meter-Check measurements on the same meter and test strip combination were within the value assignment ranges established for Meter-Check. | 100% of Meter-Check measurements on the same meter and test strip combination were within the value assignment ranges established for Meter-Check. |
| Unopened shelf-life: 2 years (24 months) at recommended storage temperatures (2°C to 30°C / 36°F to 86°F). | Demonstrated by real-time stability studies of equivalent product. |
| Stability after opening: less than 5% change in percent glucose recovery on YSI on vials evaluated of 3 months (93 days). | Met stability requirements as demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set. However, it mentions:
- "a series of measurements" were performed.
- Glucose Meter-Check Solution and mid-level Bayer quality control solution were tested "for each strip/meter type."
- The table "Evaluation of Equivalence of Control Solutions" presents data for various test strip and meter brands (Breeze 2, Contour, Contour TS, Contour Next EZ). Each row represents a "Control Brand" (Bayer's own control, Current Meter-Check, New Meter-Check) with "Pooled Mean," "Pooled SD," "Pooled CV%" implying multiple measurements were pooled for each combination.
Data Provenance:
- The document states: "Current version blood glucose meters, test strips and quality control solutions were purchased through retail outlets for Bayer blood glucose monitoring systems." This suggests the data was collected from commercially available products, likely in the country where the testing was conducted (not specified, but presumably the US where the submission was made).
- The study appears to be prospective as it involved testing the performance of the new device against existing ones.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of study does not typically involve human experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images).
For this device (a quality control solution for blood glucose meters), the ground truth is based on:
- Value assignment ranges: These ranges are established by the test strip manufacturers (Bayer in this case) and Bionostics for their Meter-Check solutions.
- Measurement against reference methods: The document mentions "determined by analysis of glucose on commercial lots of glucose test strips qualified for proper measurement using manufacturer recommended control solution" and "Traceability: N.I.S.T. SRM 917." This indicates a reliance on standardized laboratory methods and reference materials, rather than expert interpretation.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1 or 3+1) is mentioned, as this is not a study relying on human interpretation of subjective data. The assessment is objective, based on whether numerical results fall within predefined ranges.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed to evaluate the performance of human readers (e.g., radiologists, pathologists) with and without AI assistance on a set of cases. This study is for a quality control solution used to verify the performance of blood glucose meters, not for an AI algorithm assisting human interpretation. Therefore, it does not involve human readers or assess an effect size of AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the device (quality control solution) doesn't have an "algorithm" in the typical AI sense, the performance testing described is analogous to a standalone performance evaluation. The device (control solution) is used directly with blood glucose meters, and its functionality is assessed based on whether the meter/strip system produces results within established ranges when the control solution is used. There is no human intervention required to interpret the control solution's performance; the meter provides a reading, and that reading is objectively compared to the expected range.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Manufacturer-recommended value assignment ranges: These are the expected glucose values for a given meter/test strip/control solution combination.
- Traceability to N.I.S.T. SRM 917: This refers to the National Institute of Standards and Technology Standard Reference Material 917, which is a certified glucose standard, ensuring the accuracy of the glucose concentration.
- YSI analysis: The stability section mentions "percent glucose recovery on YSI," indicating that a YSI (Yellow Springs Instruments) analyzer, a highly accurate laboratory instrument, was used for reference measurements.
This type of ground truth is analogous to analytical reference methods or certified reference materials.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control solution, not an AI algorithm that requires a "training set." The product's performance is driven by its chemical formulation and manufacturing processes, not by machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.