(84 days)
LifeScan OneTouch Ultra control solution is intended for use to verify the performance of LifeScan BGM systems using the OneTouch Ultra or OneTouch FastTake test strips at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use
LifeScan OneTouch Ultra control solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. LifeScan OneTouch Ultra control solution provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. 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. LifeScan OneTouch Ultra control solution contains glucose representing typical, normal-range glucose values in blood to verify performance of LifeScan BGM systems using the OneTouch Ultra or OneTouch FastTake test strips. LifeScan OneTouch Ultra control solution is a non-hazardous aqueous solution containing no biological materials.
Here's a breakdown of the acceptance criteria and study information for the LifeScan OneTouch Ultra control solution, based on the provided text:
Acceptance Criteria and Reported Device Performance
The submission is for an extension of an existing control solution, stating "There has been no change in formulation, labeling or intended use of the control solution since the original 510(k) submission, K000318." Therefore, the acceptance criteria are implicitly tied to the performance requirements of the control solution's ability to verify the various LifeScan BGM systems. The reported performance is that the control solution successfully addresses these requirements.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Closed bottle stability | Verified |
| Stability after opening | Verified |
| Test precision and range | Verified |
The control solution's intended use is "to monitor and evaluate the analytical performance of LifeScan BGM family systems using the OneTouch Ultra or OneTouch FastTake test strips." The device performance is deemed adequate because it provides a convenient method of performing periodic QC checks and contains glucose representing typical, normal-range glucose values in blood to verify performance.
1. Sample Sized Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample sizes (number of tests, number of control solution lots, etc.) used for the non-clinical tests (closed bottle stability, stability after opening, test precision and range). No detailed testing protocols or results are included in this summary.
The data provenance is not specified beyond "Tests were conducted to verify specific performance requirements." It does not mention the country of origin of the data or whether it was retrospective or prospective.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a control solution for glucose meters, not a diagnostic device requiring expert interpretation of results. The "ground truth" for a control solution would be its known glucose concentration, established through a traceable reference method, not through expert consensus on diagnostic images or pathology.
3. Adjudication Method for the Test Set
Not applicable. As this is not a diagnostic device involving subjective interpretation, there is no adjudication process for the test set.
4. 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 is a control solution for blood glucose meters, not an AI-powered diagnostic device or a system for human readers.
5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of a control solution. A control solution itself operates "standalone" in the sense that its chemical properties and stability are assessed intrinsically. It doesn't involve a separate algorithm for interpretation in the way an AI diagnostic tool would. Its performance is measured by how well it verifies the performance of the BGM system.
6. The Type of Ground Truth Used
The ground truth for a glucose control solution's performance stability, precision, and range would be:
- Reference Glucose Concentration: The known, accurately measured glucose concentration of the control solution itself, established through highly precise and traceable chemical analytical methods.
- Performance of Predicate Device/System: The expected and validated performance (accuracy, precision) of the OneTouch Ultra and OneTouch FastTake glucose meters when measuring known glucose concentrations. The goal of the control solution is to ensure these meters perform within their established specifications.
7. The Sample Size for the Training Set
Not applicable. This is a chemical control solution, not a machine learning or AI model that requires a training set.
8. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a chemical control solution.
§ 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.