(16 days)
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.
The Liberty Glucose Normal Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
The provided text describes the 510(k) Premarket Notification for the "Liberty Glucose Normal Control Solution."
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state numerical acceptance criteria with corresponding reported device performance values in a clear table format for the Liberty Glucose Normal Control Solution itself. Instead, it refers to performance characteristics that were verified.
The performance studies mentioned were conducted to verify:
- Stability (Accelerated and Real-time)
- Open Vial
- Microbial Stress Stability
- Test precision
The conclusion stated: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence," implying that the device met the internal criteria for these characteristics,
but the specific numerical targets or results are not detailed.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify sample sizes for any of the tests performed (Stability, Open Vial, Microbial Stress Stability, Test Precision).
The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As this is a control solution for glucose meters, the "ground truth" would likely be based on established analytical methods for glucose concentration, not expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a control solution, adjudication methods common in diagnostic imaging or clinical trials involving subjective interpretation would not typically apply.
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 typically relevant for interpretative diagnostic devices (e.g., imaging AI) and explicitly measures human reader performance with and without AI assistance. This device is a control solution for glucose meters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a standalone control solution (used to verify a glucose meter's performance), the document does not describe a "standalone algorithm-only performance" study in the context of an AI/algorithm. The performance studies listed (Stability, Open Vial, Microbial Stress Stability, Test Precision) refer to the chemical and physical properties of the control solution.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For a glucose control solution, the 'ground truth' for its performance characteristics (stability, precision) would be established by:
- Analytical Chemistry Methods: The known quantity of glucose in the solution would be precisely measured using a highly accurate reference method.
- Stability Testing Protocols: Standard protocols for assessing the degradation or change in concentration over time under various conditions.
- Precision Testing Protocols: Repeated measurements to determine the reproducibility of the glucose concentration.
The document does not explicitly state the specific methods used to establish these ground truths, but it implies standard laboratory practices for quality control materials.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical control solution, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or 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.