(35 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 the Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitoring systems.
The SMS Glucose Control consists of a viscosityadjusted, 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.
Here's an analysis of the provided text regarding the 'SMS Glucose Control' device, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the 'SMS Glucose Control' does not explicitly state specific acceptance criteria (e.g., numerical thresholds for stability, precision, etc.) or detailed reported device performance values. Instead, it lists the types of performance studies conducted and concludes that these studies "support the claim of substantial equivalence" to predicate devices.
The listed performance studies are:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Stability | Supported substantial equivalence |
| Open Vial | Supported substantial equivalence |
| Microbial Stress Stability | Supported substantial equivalence |
| Test precision | Supported substantial equivalence |
Note: For this type of device (quality control material), "performance" often refers to its ability to consistently produce expected glucose readings when used with the target blood glucose monitoring systems, within a specified range, and maintain that consistency over its shelf life. The document implies that the studies demonstrated this consistency and equivalence to predicate devices, but the granular data or specific acceptance ranges are not presented.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed study reports accompanying the 510(k) submission, not necessarily in the summary itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this device. The 'SMS Glucose Control' is a quality control solution, not a diagnostic device that interprets medical images or patient data requiring expert consensus for ground truth. Its "ground truth" would be related to its manufacturing specifications (i.e., the known glucose concentration it's designed to represent) and its functional performance with specific blood glucose meters.
4. Adjudication Method
This information is not applicable as there is no diagnostic interpretation involved that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not applicable and not performed. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI on reader performance. The 'SMS Glucose Control' is a quality control material.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study in the context of an algorithm or AI was not applicable and not performed. The device is a physical control solution, not an algorithm. Its performance is assessed through its physical and chemical stability and its interaction with the specified blood glucose meters.
7. Type of Ground Truth Used
For a quality control material like the 'SMS Glucose Control', the "ground truth" is established by:
- Manufacturing Specifications: The known, precisely formulated glucose concentration within the control solution.
- Reference Method Assays: Verifying the actual glucose concentration of the control solution against highly accurate and traceable laboratory reference methods.
- Performance with Predicate Devices: Ensuring the control solution produces expected and consistent results within predefined ranges when tested on the specified blood glucose monitoring systems (Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitoring systems).
The document implies these types of internal validations were performed to ensure the control solution was fit for its intended purpose and substantially equivalent to existing controls.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/algorithm that requires a training set. The "training" for a manufacturing process would relate to process validation and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device does not involve an AI/algorithm with a training set.
§ 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.