(40 days)
Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose Monitoring System is intended for use to verify the performance of the Chdiagnostics Senova™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use
Glucose Control Solution for Chdiagnostics Senova™ is a three-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Control Solution for Chdiagnostics Senova™ 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 blue color to help users see the solution while dispensing onto a test strip. Glucose Control Solution for Chdiagnostics Senova™contains glucose values at three points within the reportable range and to verify performance of the Chdiagnostics Senova™ BGM. Glucose Control Solution for Chdiagnostics Senova™ is a non-hazardous aqueous solution containing no biological materials.
The provided text describes a 510(k) premarket notification for a medical device called "Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's diagnostic performance against specific acceptance criteria.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not directly addressed in the provided text. The device is a control solution, designed to verify the performance of a blood glucose monitoring (BGM) system, not a diagnostic device itself that measures a patient's condition.
Here's an attempt to answer the questions based on the available information, noting where information is not provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria in terms of performance metrics (e.g., accuracy percentages, sensitivity, specificity) for the control solution itself. Instead, it describes general performance requirements that were verified.
| Acceptance Criteria (Implied) | Reported Device Performance (as tested) |
|---|---|
| Closed bottle stability | Tests were conducted to verify. (Specific results not provided in this summary) |
| Stability after opening | Tests were conducted to verify. (Specific results not provided in this summary) |
| Correlation to gravimetric D-glucose | Tests were conducted to verify. (Specific results not provided in this summary) |
| Test precision and range | Tests were conducted to verify. (Specific results not provided in this summary) The control contains glucose values at three points within the reportable range of the Chdiagnostics Senova™ BGM. |
| Simulates whole blood response | Optimized to simulate the response of whole blood on the Chdiagnostics Senova™ BGM system. |
| Non-hazardous aqueous solution | Stated as a characteristic. |
| No biological materials | Stated as a characteristic. |
| Three-level control | Confirmed as a three-level control. |
| Viscosity-adjusted | Confirmed as viscosity-adjusted. |
| Packaged in plastic bottles with dropper tips | Confirmed. |
| Blue color to aid dispensing | Confirmed. |
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 the sample sizes used for the non-clinical tests (closed bottle stability, stability after opening, correlation to gravimetric D-glucose, test precision, and range). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This device is a control solution for a glucose meter. The "ground truth" for its performance would typically involve analytical chemistry methods and standardized testing protocols, such as gravimetric analysis for glucose concentration. The document does not specify the number or qualifications of experts involved in establishing this analytical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method, as it's not relevant for the type of non-clinical analytical testing performed for a control solution.
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
An MRMC comparative effectiveness study is not applicable as this device is a control solution, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable as the device is a control solution, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the glucose concentration of the control solution would likely be established through laboratory analytical methods, such as gravimetric D-glucose analysis, which is mentioned in the "Summary of non-clinical tests."
8. The sample size for the training set
This is not applicable as the device is a chemical control solution and does not involve machine learning algorithms that require a "training set."
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.