(29 days)
The Rightest Control Solutions GC300 are for use with the Rightest Blood Glucose Meter GM300 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly.
The Rightest Control Solutions GC100 are for use with the Rightest Blood Glucose Meter GM100 and the Rightest Blood Glucose Test Strip GS100 to check that the meter and test strips are working together properly and that the test is performing correctly.
The Rightest Control Solutions GC110 are for use with the Rightest Blood Glucose Meter GM110 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly.
The Rightest Control Solutions GC310 are for use with the Rightest Blood Glucose Meter GM310 and the Rightest Blood Glucose Test Strip GS310 to check that the meter and test strips are working together properly and that the test is performing correctly.
Rightest Control Solution is a single-level, aqueous liquid qlucose control solution containing a measured amount of qlucose that reacts with the test strips to provide a Quality Control Result. This result should fall within the expected range printed on the Test Strip vial, and will verify if the meter and the test strips are working properly. The Rightest Control Solution has a red color to help users see the solution while dispensing onto a test strip.
Rightest Control Solution is a non-hazardous aqueous glucose control solution containing no human or animal derived materials.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Value Assignment Procedure: | Met: |
| - Data from repeated measurement evaluated by ANOVA analysis. | - "Data from repeated measurement will first be evaluated by ANOVA analysis." (Implied met, as study proceeded to determine mean/CV). |
| - Acceptable range of measurement: ±15% of Mean value. | - "Only after passing the ANOVA analysis, the data from repeated measurement can proceed to determine mean/CV to establish an acceptable range. The acceptable range of measurement as ±15% of Mean value to correspond to the value assignment ranges currently provided by using Rightest test strips. The test result should fall within the expected range printed on the Test Strip vial, and will verify if the meter and the test strips are working properly." (Implied met, as the acceptable range was established and the conclusion states performance was demonstrated.) |
| Closed Bottle Stability (Shelf-Life): | Met: |
| - 1.5 years (18 months) at 2-30°C. | - "Stability characteristics were determined under unopened conditions in real time and accelerated stability studies to demonstrate an closed shelf-life of 1.5 years (18 months) at the recommended storage temperatures, ranging from 2-30°C (36-86°F)." |
| Opened Bottle Stability (Open-Vial): | Met: |
| - 3 months (20 weeks) with less than 10% bias of week 0 values. | - "Rightest Control Solution meets stability requirements in real-time stability study as demonstrated by less than 10% bias of week 0 values with an open-vial claim of 3 months (20 weeks)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Value Assignment: Total of 30 measurements for each test strip type. This was derived from using three lots of control solutions and ten blood glucose meters.
- Data Provenance: The document does not explicitly state the country of origin for the data for the value assignment study. However, the submitter's identification is "BIONIME CORPORATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412," suggesting the studies were likely conducted in Taiwan. The studies were prospective as per the description of the testing procedures (e.g., stability studies involving real-time measurements).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is a control solution for blood glucose meters, not a diagnostic device that requires human interpretation of images or complex data. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists) does not apply.
Instead, the "ground truth" or reference values are established through a statistical process of repeated measurements using the meters and test strips designed to work with the control solution, and then defining an acceptable deviation (±15% of the mean). The expertise involved would be in the design and execution of these analytical studies and the interpretation of statistical results, rather than clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for this type of device is established through an analytical and statistical process involving repeated measurements, ANOVA analysis, and establishing a mean and acceptable range (±15% of the mean). There is no mention of human adjudication for individual test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret cases, and the AI's role is to assist or augment that interpretation. This submission is for a control solution, an in-vitro diagnostic (IVD) analytical reagent, which verifies the proper functioning of a blood glucose monitoring system, not for a device that involves human interpretation of medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a control solution, not an algorithm or AI. Therefore, the concept of a "standalone algorithm performance" study is not applicable. The performance evaluated is the ability of the control solution to produce results within a defined range when used with the specified blood glucose meters and test strips.
7. The Type of Ground Truth Used
The ground truth used for establishing the acceptable ranges of the control solution is based on an analytical reference method where:
- Repeated measurements of the control solution are taken using multiple test strips and meters.
- Statistical analysis (ANOVA) is applied to these measurements.
- A mean value is determined, and an acceptable range is established as ±15% of that mean value.
This is effectively an empirical, statistically derived ground truth based on the expected performance characteristics of the glucose monitoring system components (meters and test strips) when reacting with the control solution.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI, as the device is not an algorithm. However, if we interpret "training set" as the data used to establish the reference values or expected performance of the control solution:
- For the value assignment procedure: The data used consisted of measurements from three lots of control solutions and ten different blood glucose meters for each test strip type. This provided 30 measurements for each test strip type. This data was used to establish the mean and acceptable ranges.
- For stability studies: The document states "real time and accelerated stability studies" were conducted, implying ongoing monitoring over time, which would involve a dataset gathered over the stability period. Specific sample sizes for these continuous measurements are not provided beyond the general description.
9. How the Ground Truth for the Training Set Was Established
As noted above, for the value assignment, the ground truth was established through a rigorous analytical characterization process:
- Repeated measurement: The control solution was repeatedly tested using a defined set of meters and test strips.
- ANOVA analysis: Statistical analysis (ANOVA) was performed to evaluate the data from these repeated measurements, likely to ensure consistency across lots and meters.
- Mean and acceptable range determination: After passing ANOVA, the data was used to calculate a mean value. This mean then formed the basis for the "ground truth" reference range, with an acceptable deviation defined as ±15% of the mean value. This range corresponds to existing assigned values for the Rightest test strips.
This process ensures that the control solution's expected readings are consistent with the established performance specifications of the blood glucose monitoring system it is intended to verify.
§ 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.