(37 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 Abbott Medisense Optium, Precision, Precision 3, and Precision Xtra Blood Glucose Monitors.
The Liberty Glucose Control MID consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of qlucose. 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 non-hazardous and contains no human or animal derived materials.
The provided text describes a 510(k) submission for the "Liberty Glucose Control MID" and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs, or performance results in the format requested.
The document states that "Tests were performed to verify specific performance characteristics: 1. Stability (Accelerated and Real-time), 2. Open Vial, 3. Microbial Stress Stability, 4. Test precision." It then concludes that "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence," implying these tests were sufficient to meet regulatory requirements.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
The document focuses on the regulatory submission rather than a detailed scientific study report with specific performance metrics against defined acceptance criteria.
§ 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.