(27 days)
Multi-Meter Glucose Calibration Verification Material 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
Multi-Meter Glucose Calibration Verification Material is a five-level, viscosityadjusted, aqueous liquid glucose control linearity set. Multi-Meter Glucose Calibration Verification Material 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. Multi-Meter Glucose Calibration Verification Material 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, for each of a number of blood glucose meters listed on the package insert. Multi-Meter Glucose Calibration Verification Material is a non-hazardous aqueous solution containing no biological materials.
Here's an analysis of the provided text regarding the Bionostics Multi-Meter Glucose Calibration Verification Material, focusing on acceptance criteria and study details:
Device: Bionostics Multi-Meter Glucose Calibration Verification Material
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K012430 does not explicitly state specific quantitative acceptance criteria for the Multi-Meter Glucose Calibration Verification Material. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through qualitative and common performance characteristics.
However, based on the non-clinical tests conducted, we can infer the types of performance attributes that would have been evaluated to meet implied acceptance criteria.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Stability (Shelf-life) | Supported by accelerated aging studies on most labile analytes and experience with similar formulations. (Specific timeframes or limits not provided). |
| Precision | Test precision was evaluated. (Specific precision values or limits not provided). |
| Correlation to Reference Methodology | Correlation to reference methodology was evaluated. (Specific correlation coefficients or limits not provided). |
| Linearity/Calibration Verification | Contains glucose values at lower/upper reportable range and three points within, suitable for assessing linearity and calibration. |
| Simulated Whole Blood Response | Optimized to simulate whole blood response on listed blood glucose meters. |
| Safety (Non-hazardous) | Non-hazardous aqueous solution, no biological materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human data or a specific dataset for performance evaluation. Instead, it refers to "non-clinical tests" to verify performance requirements.
- Sample Size for Test Set: Not explicitly stated. The tests conducted were likely laboratory-based experiments involving multiple samples of the material itself, measured across various glucose meters.
- Data Provenance: The studies were non-clinical (laboratory-based) and were conducted by Bionostics, Inc. in Acton, MA, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission. There is no mention of country of origin for patient data as this is a control material, not a diagnostic device directly interacting with patient samples for primary diagnosis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the submission. The device is a calibration verification material, and its "ground truth" would be established by the known, certified glucose concentration levels within the material itself, as measured by a reference method, not by expert interpretation of images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results (e.g., radiology images) by multiple experts. For a control material, the "assessment" is based on analytical measurements against known values and technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Bionostics Multi-Meter Glucose Calibration Verification Material is a laboratory control solution, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study was Done
No, a standalone (algorithm only) performance study was not done. This device is a control material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for this device would be established by:
- Reference Methodology: The concentrations of glucose in the five levels of the control material would be accurately measured and verified using a highly accurate and precise reference method (e.g., enzymatic reference methods traceable to standard reference materials).
- Formulation Specifications: The ground truth for stability and other characteristics would be tied to the chemical formulation and manufacturing specifications to ensure consistent and accurate glucose levels.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a chemical control solution, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, 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.