(67 days)
Glucose Meter-Check" Solution is intended to assess the performance of the following Roche ACCU-CHEK blood glucose test systems:
Roche ACCU-CHEK Advantage using Comfort Curve® test strips '
- Roche ACCU-CHEK Active® ・
- · Roche ACCU-CHEK Aviva®
Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® .
The Meter-Check Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Glucose Meter-Check Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check "Control Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. 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.
Glucose Meter-Check Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.
The provided text describes a 510(k) submission for a medical device called "Glucose Meter-Check™ Control Solution for Roche ACCU-CHEK." This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria in the typical sense of a clinical trial for diagnostic performance.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in the provided documentation. The acceptance criteria in this context are for demonstrating substantial equivalence based on technological characteristics and performance verification that would typically be done in a lab.
Here's an analysis based on the information provided, addressing as many points as possible:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of specific acceptance criteria in the traditional clinical performance sense (e.g., sensitivity, specificity thresholds) nor does it report device performance against such criteria. Instead, it focuses on verifying a few specific performance requirements for a control solution.
| Acceptance Criteria (Implied / Verified) | Reported Device Performance (Summary) |
|---|---|
| Closed bottle stability | Tests were conducted to verify. |
| Stability after opening | Tests were conducted to verify. |
| Bias to glucose as determined by YSI 2300 | Tests were conducted to verify. |
| Test precision and range | Tests were conducted to verify. |
| Substantial equivalence to predicate devices based on: | Comparison of technological characteristics, formulation, and intended use supports substantial equivalence. |
| - Net Fill | 4 mL |
| - Color | red |
| - Analyte | glucose |
| - Container | plastic vial |
| - Matrix | aqueous |
| - Level | normal |
| - Mid Assigned Range | 107 |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the "tests were conducted to verify" sections (closed bottle stability, open bottle stability, bias, precision, and range). These are likely laboratory-based studies. No information is provided about data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The verification tests performed for this control solution do not involve human expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as the device is a control solution, and its performance is assessed through analytical tests, not human interpretation.
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
Not applicable. This device is a glucose control solution, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a control solution, not an algorithm. Its performance is inherent to its chemical and physical properties.
7. The type of ground truth used
For the analytical tests (stability, bias, precision, range), the "ground truth" would be established by reference methods or established laboratory standards (e.g., YSI 2300 for glucose bias).
8. The sample size for the training set
Not applicable. This device is a control solution, and its development does not involve machine learning or a "training set" in that sense.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned or implied 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.