(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.
{0}------------------------------------------------
KG71014
510(k) Summary Summary of Safety and Effectiveness
APR
23 1997
| Submitter | LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035Judy Martin, RAC |
|---|---|
| Date | March 18, 1997 |
| Proprietary Name | LifeScan SureStep®Pro Glucose ControlSolutions (Low, Normal and High)LifeScan SureStep®Pro Linearity Test Kit |
| Common Name | Single (specified) Analyte Control (Assayed) |
| Classification Name | 21 CFR 862.1660, Quality Control Material(assayed and unassayed) - (75JJX) |
Device Description
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.
015
{1}------------------------------------------------
Intended Use
The intended use of the LifeScan SureStep®Pro Glucose Control Solutions and the currently marketed SureStep® Glucose (Normal) Control Solution is identical. The intended use for the SureStep®Pro Glucose Control Solutions is as follows:
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 intended use of the LifeScan SureStep®Pro Linearity Test Kit is equivalent to the Streck Sugar-Chex® Linearity kit with the exception that the SureStep®Pro Linearity Test Kit is not intended for calibration assessment. The intended use for the SureStep®Pro Linearity Test Kit is as follows:
The SureStep®Pro Linearity Test Kit is for use with SureStep® Brand Glucose Meters and SureStep Pro Test Strips for verification of System linearity.
Substantial Equivalence
The LifeScan SureStep Pro Glucose Control Solutions (Low, Normal and High) and Linearity Test Kit are substantially equivalent to the currently marketed LifeScan SureStep® Glucose (Normal) Control Solution and Streck Laboratories Sugar-Chex® Linearity kit, respectively.
016
§ 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.