(34 days)
SureStep®Pro Glucose Control Solutions are for use with SureStep® Brand Blood Glucose Meters and SureStep®Pro Test Strips as a quality control material for verification of System performance.
The SureStep®Pro Linearity Test Kit is for use with SureStep® Brand Glucose Meters and SureStep Pro Test Strips for verification of System linearity.
The SureStep®Pro Glucose Control and Linearity Test Solutions are designed for use with LifeScan SureStep® Brand Blood Glucose Meters and SureStep®Pro Brand Test Strips.
SureStep®Pro Glucose Control Solutions contain a measured amount of glucose that reacts with the SureStep®Pro Test Strips. When using the same procedure as testing with whole blood, the control solution should provide results within the expected SureStep®Pro Glucose Control Solution range printed on the test strip bottle. Obtaining results outside the expected range indicates the System is not performing correctly.
The SureStep®Pro Linearity Test Solutions contain a measured amount of glucose. When the linearity solution is applied to a SureStep®Pro Test Strip in the same manner as the glucose controls the results are used to verify System linearity.
The provided text describes a medical device, the LifeScan SureStep®Pro Glucose Control Solutions and Linearity Test Kit, and its intended use, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.
Therefore, I cannot fulfill your request for a table outlining acceptance criteria and reported device performance or details about the study that proves the device meets those criteria. The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific 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.