(40 days)
Glucose Meter-Check Solution for Infopia is intended for use to verify the performance and correct operation of Infopia blood glucose monitoring test systems utilizing Infopia glucose test strips. Glucose Meter-Check Solution for Infopia is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Solution is formulated for optimal performance on Infopia glucose meters using Infopia test strips.
This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range corresponding to Interval 2 of the glucose contration intervals for evalution of intermediate precision in ISO 151972 (96 to 144 mg/dL). This solution has been optimized to simulate the response of whole blood on the blood glucose test systems manufactured by Infopia using Infopia blood glucose test strips. The solution contains no hazardous, human or animal derived components.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Glucose Meter-Check Solution for Infopia:
The submission K113764 is for a control solution, not an AI device, and therefore the majority of the requested information regarding AI device evaluation (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes the equivalence of a new control solution to an existing one.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a control solution are typically defined as its ability to produce glucose readings within a specified target range when tested with the intended blood glucose monitoring system. The predicate device's established target range serves as the basis for substantial equivalence.
| Acceptance Criteria (Predicate Device Target Range) | Reported Device Performance (New Device Target Range) |
|---|---|
| 94 – 140 mg/dL | 88 – 132 mg/dL |
Note: The new device's target range (88 – 132 mg/dL) falls within the established performance window for glucose concentration intervals for evaluation of intermediate precision in ISO 15197 (96 to 144 mg/dL), and is deemed substantially equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a medical device submission for a control solution, and not an AI device undergoing a performance study with a test set of data. The "tests conducted" section lists stability and response tests, but does not detail sample sizes as would be relevant for an AI model's test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. Ground truth, in the context of an AI device, refers to expertly curated data for model comparison. For a control solution, the "truth" is its certified glucose concentration, which is established through analytical chemistry, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not pertinent to the evaluation of a glucose control solution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which doesn't apply to a control solution.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop) Was Done
This information is not applicable. There is no algorithm or AI component in this control solution.
7. The Type of Ground Truth Used
For the Glucose Meter-Check Solution, the "ground truth" implicitly refers to the analytical concentration of D-glucose in the buffered aqueous solution, established through chemical manufacturing and quality control processes. This is confirmed by the statement: "Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose..." and its formulation "with a single concentration of D-glucose".
8. The Sample Size for the Training Set
This information is not applicable, as there is no AI model or training set associated with this control solution.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no AI model or training set associated with this control solution.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria for this control solution primarily focuses on non-clinical tests comparing its characteristics and performance to a legally marketed predicate device (Infopia Control Solution K0572369).
The key aspects of the study demonstrating substantial equivalence include:
- Comparison of Technological Characteristics: A direct comparison table is provided, showing the new device shares fundamental characteristics with the predicate, such as:
- Name (Infopia Control Solution vs. Glucose Meter-Check Control Solution for Infopia)
- Number of levels (1, typical fasting glucose)
- Analytes (glucose)
- Container (6 mL LDPE vial with dispensing tip and cap)
- Fill volume (4 mL)
- Color (red)
- Matrix (Buffered, aqueous solution of D-Glucose, viscosity modifier, preservatives and other, non-reactive ingredients)
- Target Ranges: The new device's target range (88 – 132 mg/dL) was established and deemed acceptable when compared to the predicate's range (94 – 140 mg/dL). This range is also stated to correspond to Interval 2 of the glucose concentration intervals for the evaluation of intermediate precision in ISO 15197 (96 to 144 mg/dL), implying it meets recognized standards for control solution performance.
- Non-Clinical Performance Tests: The submission states that tests were conducted to verify specific performance requirements:
- Closed bottle stability (Shelf-life)
- Stability after opening (Use-life)
- Transport Stability
- Test response (This implicitly confirms that the solution provides readings within its specified range on the target glucose meters).
Conclusion drawn from these tests: "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." This means the new Glucose Meter-Check Solution for Infopia performs comparably to the predicate control solution, within acceptable parameters, ensuring it can effectively verify the performance of Infopia blood glucose monitoring test systems as intended.
§ 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.