(51 days)
Glucose Control Solution for BD Latitude™ Blood Glucose Monitoring System is intended for use to verify the performance of the BD Latitude™ 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 BD Latitude™ is a three-level, viscosityadjusted, aqueous liquid glucose control solution. Glucose Control Solution for BD Latitude™ 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 BD Latitude™ contains glucose values at three points within the reportable range and verifies performance of the BD Latitude ™ BGM.
Glucose Control Solution for BD Latitude™ is a non-hazardous aqueous solution containing no biological materials.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Glucose Control Solution for BD Latitude™:
The provided document is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data in the format of a typical study report. Therefore, direct answers to all your questions are not explicitly available or are inferred from the context of a 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not present a formal table of acceptance criteria with specific numerical targets and corresponding performance results. Instead, it lists the types of tests conducted to ensure performance requirements are met, implying that the results of these tests demonstrated acceptable performance relative to existing, legally marketed predicate devices.
| Acceptance Criteria Type (Inferred) | Reported Device Performance |
|---|---|
| Closed Bottle Stability | Tests conducted to verify specific performance requirements. (Implied acceptable stability for shelf life) |
| Stability After Opening | Tests conducted to verify specific performance requirements. (Implied acceptable stability for use life) |
| Correlation to Gravimetric D-Glucose | Tests conducted to verify specific performance requirements. (Implied acceptable correlation to a reference method) |
| Test Precision and Range | Tests conducted to verify specific performance requirements. (Implied acceptable precision and accurate glucose values within the reportable range of the BD Latitude™ BGM) |
| Manufacturing Process (as per predicate) | Substantially equivalent to predicate device in characteristics, formulation, and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the non-clinical tests. It only states that "Tests were conducted to verify specific performance requirements." Similarly, it does not provide details on the data provenance (e.g., country of origin, retrospective/prospective), as this level of detail is typically not included in a 510(k) summary that focuses on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not provided. For a control solution, "ground truth" would typically refer to the accurately measured glucose concentrations within the control solutions themselves. This is established through rigorous analytical chemistry methods rather than expert consensus on diagnostic images or clinical assessments.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of diagnostic data (e.g., medical images) where there can be inter-reader variability. For a chemical control solution, the 'ground truth' values are determined analytically, not through human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study is not relevant for a glucose control solution. This type of study is used to evaluate the impact of an AI system on human reader performance in diagnostic tasks.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The device is a glucose control solution, not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The "performance" of this device is its ability to provide stable, accurate, and consistent glucose values that can be used to verify the performance of a blood glucose meter. The non-clinical tests assess these inherent properties.
7. The Type of Ground Truth Used
The ground truth for the control solution's glucose concentration would be established through gravimetric D-glucose (as mentioned in the summary, "Correlation to gravimetric D-glucose"). This is a highly accurate chemical reference method for determining glucose concentration.
8. The Sample Size for the Training Set
Not applicable. The device is a chemical control solution, not an AI/ML algorithm that requires 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.
In summary, the provided 510(k) summary focuses on demonstrating that the Glucose Control Solution for BD Latitude™ is substantially equivalent to a legally marketed predicate device. It explicitly states that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." The non-clinical tests listed (stability, correlation to gravimetric D-glucose, precision, and range) are the types of studies typically performed to ensure the quality and reliability of a control solution, but the detailed results and specific acceptance criteria are not presented in this summary document.
§ 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.