(57 days)
RNA GLA Glucose Calibration Verification Control assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems' performance.
For In Vitro Diagnostic Use
RNA GL4 Glucose Calibration Verification Control is a seven-vial, viscosityadjusted, aqueous liquid glucose control linearity set which provides two, five-level CVC sets, optimized for use with MediSense Point of Care blood glucose systems PCx and i-STAT 1 using Precision PCx or Precision PCx Plus test strips. RNA GL4 Glucose Calibration Verification Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. 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.
RNA GL4 Glucose Calibration Verification Control contains glucose values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance of the blood glucose systems listed on the package insert.
RNA GL4 Glucose Calibration Verification Control is a non-hazardous aqueous solution containing no biological materials.
The provided text describes the Bionostics RNA GL4 Glucose Calibration Verification Control, a device used to verify the analytical performance of blood glucose meters. It does not contain information about acceptance criteria or a specific study designed to prove the device meets these criteria in the manner one would expect for a diagnostic or AI device.
However, based on the information provided, here's a breakdown of what can be extracted, and where there are gaps in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, precision limits) for the RNA GL4 Glucose Calibration Verification Control. It mentions the "intended use to verify the analytical performance" and to "assess the linearity and calibration, or verify performance."
The device performance is described by its characteristics and its ability to provide specific glucose concentrations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Verification of Analytical Performance | Intended for use to verify the analytical performance of certain blood glucose meters (PCx and i-STAT 1). |
| Assessment of Linearity and Calibration | Contains glucose values at the lower and upper limits of reportable range as well as three points within the range, allowing for assessment of linearity and calibration. |
| Specific Glucose Concentrations | Provides seven specific glucose concentrations optimized to simulate whole blood response for listed blood glucose meters/test strips. |
| Stability | Accelerated aging studies on most labile analytes, together with real time experience with products with similar formulations, support stability claim. |
| Precision | Test precision was conducted. (No specific results provided). |
| Correlation to Reference Methodology | Correlation to reference methodology was conducted. (No specific results provided). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a study with a sample size for evaluating the device's performance against clinical data or a ground truth. Instead, it discusses:
- Accelerated aging studies and real-time experience: This implicitly involves testing the product over time, but no sample sizes or data provenance are mentioned.
- Test precision: This refers to internal testing of the control solution itself, not a test set of patient samples. No sample size is given.
- Correlation to reference methodology: This also refers to internal testing of the control. No sample size or data provenance is given.
This device is a calibration verification control, meaning it's a known standard used to check the performance of a blood glucose meter, not a diagnostic device that processes patient samples to generate an output. Therefore, the concept of a "test set" with patient data as typically understood for a diagnostic algorithm is not directly applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is a control solution, the "ground truth" for its own stated glucose concentrations would be established through precise chemical analysis and manufacturing controls, not through expert consensus on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" involving patient data and multiple readers or experts to require an adjudication method.
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
Not applicable. This device is a calibration control, not an AI-powered diagnostic tool, and therefore MRMC studies with human readers are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. It's a laboratory reagent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the RNA GL4 Glucose Calibration Verification Control itself would be the analytically determined and precisely manufactured concentrations of glucose in each of its seven solutions (A through G). These concentrations are specified as "target midpoint values" (e.g., 40 mg/dL, 103 mg/dL, 440 mg/dL). This is established through rigorous chemical and metrological standards, not expert consensus on pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is a control solution, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this product.
§ 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.