(92 days)
The FDI Glucose Controls are intended for use with Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly.
The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.
The FDI Glucose Controls for the Embrace No Code consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control and a red coloration to aid the user to visually confirm application. The product is non-hazardous and contains no human or animal derived materials.
The provided document is a 510(k) summary for a medical device called "FDI Level I and Level II Glucose Controls for the Embrace No Code." This device is a quality control solution for a blood glucose meter, not a diagnostic device that performs analysis or diagnosis. Therefore, several of the requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of submission.
Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant for a quality control device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Details |
|---|---|
| Real Time Stability (Shelf Life) | Acceptance Criteria: Not explicitly stated as a numerical value, but implied to demonstrate a shelf life of 24 months. |
| Reported Device Performance: Samples were periodically removed and tested in triplicate on a commercially available clinical chemistry analyzer. The study supports a shelf life of 24 months when stored at 15–30℃. | |
| Open Vial Stability | Acceptance Criteria: Not explicitly stated as a numerical value, but implied to demonstrate an open vial stability of 90 days. |
| Reported Device Performance: Test and control vials were evaluated for 13 weeks. Each day, test group vials were opened, stood for ten minutes, then closed and stored at room temperature. Weekly, one test vial and one control vial were assayed in triplicate using the ACE Glucose assay. The study supports the claimed open vial stability of 90 days when stored at 15 - 30°C. | |
| Value Assignment (Target Range) | Acceptance Criteria: Acceptable ranges for each control level are generally determined by calculating ± 20% of each control lot's calculated mean for three lots of strips. This suggests that the measured glucose values from the control solution, when tested on the Embrace No Code meter, should fall within a specific range established by the manufacturer, which is based on a ±20% variation around the mean and a ±5% lot-to-lot variability. |
| Reported Device Performance: | |
| Level I: Target Range (mg/dL) can vary lot-to-lot, but compared to predicate (88-136 mg/dL), the new product appears to maintain similar target ranges (e.g. 0.07% Glucose compared to 0.08% for predicate). | |
| Level II: Target range for the new product is 179 - 275 mg/dL, compared to 174 - 269 mg/dL for the predicate, indicating similar performance. | |
| Traceability | Acceptance Criteria: Traceability to a recognized standard (NIST SRM 917). |
| Reported Device Performance: Each control is traceable to a 70 mg/dL (Low) and a 150 mg/dL (High) in-house Standard, which are themselves traceable to the NIST Standard Reference Material 917. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the device is a control solution, not a diagnostic test being evaluated for clinical performance on patient samples. The "test set" in this context refers to the samples of the control solution itself, tested for stability and value assignment.
- Real Time Stability: Samples were "periodically removed" and "tested in triplicate." The exact number of control solution samples tested over the 24-month period is not specified.
- Open Vial Stability: A "number of test and control vials" was evaluated for 13 weeks. Weekly, "one test group vial and one control group vial was assayed in triplicate." The exact initial number of vials is not specified.
- Value Assignment: The control solutions are analyzed using "a single Embrace No Code monitor," "three different lots of test strips," and "10 replicates per strip lot, over three days." This indicates 30 measurements per control level per lot of test strips across three days.
- Data Provenance: Not specified, but generally, such studies are conducted in-house by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The "ground truth" for a control solution relates to its known glucose concentration, which is established through analytical chemistry methods and traceability to reference standards like NIST SRM 917, not through expert consensus or clinical diagnosis.
4. Adjudication Method
This is not applicable for a control solution. Adjudication methods are used in studies involving subjective interpretation of results, typically by human readers (e.g., radiologists, pathologists), to resolve discrepancies.
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
This is not applicable. The device is a quality control solution for a blood glucose meter, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical control solution, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the glucose control solutions is established by:
- Traceability to NIST Standard Reference Material 917 (SRM917): This is a primary reference material for glucose. The in-house standards are produced using SRM917, and the control solutions are then referenced to these in-house standards.
- Analytical Chemistry Methods: The manufacturing process involves precise formulation to achieve specific glucose concentrations. "Value Assignment" refers to the process of confirming these known concentrations when tested with the Embrace No Code meter.
8. The Sample Size for the Training Set
This is not applicable as the device is a quality control solution, not a machine learning algorithm that requires a training set. The term "training set" is generally used in the context of AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 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.