(129 days)
OMNIS Health Embrace Glucose Control Solution is intended for in vitro diagnostic use to assess the performance of the OMNIS Health Embrace blood glucose test systems by healthcare professionals and in the home by people with diabetes mellitus.
OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution. OMNIS Health Embrace Glucose Control Solution is intended for use to verify the performance of OMNIS Health Embrace blood glucose test systems at glucose levels within the normal fasting blood glucose range for non-diabetic persons, and at elevated ranges consistent with hyperglycemia. 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. OMNIS Health Embrace Glucose Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.
The provided 510(k) summary for the “OMNIS Health Embrace Glucose Control Solution” describes a quality control product for a blood glucose test system, not a diagnostic device that performs analysis or makes a diagnosis. Therefore, the typical acceptance criteria and study designs applicable to diagnostic devices with human subject data (e.g., sensitivity, specificity, MRMC studies, expert ground truth) are not relevant here.
Instead, the study presented focuses on the performance and stability of the control solution itself, ensuring it functions correctly to verify the performance of the glucose test system it's designed for.
Here is an analysis based on the information provided, tailored to the nature of this device:
Acceptance Criteria and Device Performance for OMNIS Health Embrace Glucose Control Solution
The OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution intended to verify the performance of OMNIS Health Embrace blood glucose test systems. The acceptance criteria for such a product relate to its stability and its ability to consistently provide a known glucose value for quality control.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list quantitative acceptance criteria values for each test. However, it indicates types of performance requirements that were met, which imply underlying acceptance criteria (e.g., stability within a defined range, consistent mean response).
| Acceptance Criteria Type | Reported Device Performance/Verification |
|---|---|
| a) Closed bottle stability (Shelf-life) | Tests were conducted to verify. (Implies performance met predefined shelf-life specifications.) |
| b) Stability after opening (Use-life) | Tests were conducted to verify. (Implies performance met predefined use-life specifications.) |
| c) Transport Stability | Tests were conducted to verify. (Implies performance maintained stability under transport conditions.) |
| d) Preservative Efficacy | Tests were conducted to verify. (Implies the preservative successfully maintained the solution's integrity.) |
| e) Test mean response and precision data | Tests were conducted to verify. (Implies consistent and precise glucose readings when used with the OMNIS Health Embrace blood glucose test systems, likely falling within established reference ranges). |
Note on "Mid Assigned Value": The comparison table with predicate devices lists "Mid Assigned Value*" for L1 (low) and L2 (high) levels as 114 mg/dL and 229 mg/dL respectively. This is not a performance result of the control solution itself when tested, but rather the target value (mid-point of assigned ranges on OMNIS Health glucose test strips) that the control solution is calibrated to represent. The "test mean response and precision data" likely confirmed that when the control solution was tested with the OMNIS Health Embrace system, the results fell within the expected range around these assigned values with acceptable precision.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample sizes (number of samples, replicates, or batches) used for each of the non-clinical tests (shelf-life, use-life, transport stability, preservative efficacy, mean response, and precision).
The data provenance is implied to be retrospective from internal non-clinical testing conducted by Bionostics, Inc. The country of origin of the data is USA, where Bionostics, Inc. is located.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable for this type of device and study. The "ground truth" for a control solution is typically established through analytical chemistry methods to determine the precise concentration of the analyte (D-glucose) and then verified through rigorous testing on the target device. It does not involve human expert interpretation of a diagnostic output in the same way clinical diagnostic devices do.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation of results or images. For a control solution, the "ground truth" (the known glucose concentration) is analytically determined, and the device's performance is assessed against this known value using objective, quantitative metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically reserved for diagnostic imaging or interpretation devices where human readers play a critical role in the diagnostic process and the effectiveness of AI assistance needs to be evaluated. This device is a quality control solution and does not involve human interpretation in its primary function.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone study" usually refers to diagnostic algorithms, the non-clinical tests described (stability, mean response, precision) function as an "algorithm only" equivalent in verifying the intrinsic properties and performance of the control solution itself. These studies assess the chemical and physical characteristics of the control solution independently of a human user's interpretation of its results. The OMNIS Health Embrace Glucose Control Solution's performance is measured by how consistently it produces expected results on the OMNIS Health Embrace blood glucose test systems, rather than by its own diagnostic output.
7. The Type of Ground Truth Used
The ground truth for this device is based on analytical chemistry standards and established reference values for glucose concentration. The "Mid Assigned Values" (e.g., 114 mg/dL and 229 mg/dL) represent the target, known concentrations that the control solution is designed to mimic when tested by the OMNIS Health Embrace blood glucose test system. The control solution itself is the ground truth for the system it's meant to evaluate.
8. The Sample Size for the Training Set
Not applicable. The OMNIS Health Embrace Glucose Control Solution is a manufactured chemical product, not an algorithm that requires a training set. The "development" and "optimization" mentioned in the description ("optimized to simulate the response of whole blood") refer to formulation adjustments and testing during product development, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is a chemical product, not an algorithm.
§ 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.