LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
Applicant
Lifescan, Inc.
Product Code
JJX · Clinical Chemistry
Decision Date
Apr 23, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1660
Device Class
Class 1
Indications for Use
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.
Device Story
SureStep®Pro Glucose Control and Linearity Test Solutions; aqueous glucose-based solutions; used with SureStep® blood glucose meters and test strips. Control solutions verify system performance by comparing meter results against expected ranges printed on test strip bottles. Linearity test solutions verify system linearity across measurement range. Used in clinical or home settings by patients or healthcare providers. Output provides qualitative/quantitative verification of system accuracy; failure to fall within expected ranges indicates system malfunction. Benefits patient by ensuring reliable glucose monitoring results.
Clinical Evidence
Bench testing only. Performance verified by comparing meter results using control/linearity solutions against established expected ranges to confirm system accuracy and linearity.
Technological Characteristics
Aqueous glucose-based solutions; formulated to provide specific glucose concentrations for system verification. Compatible with SureStep® brand meters and test strips. No electronic components, software, or connectivity.
Indications for Use
Indicated for use by healthcare professionals or patients as a quality control material to verify performance and linearity of LifeScan SureStep® Brand Blood Glucose Meters and SureStep®Pro Test Strips.
Regulatory Classification
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.
Predicate Devices
LifeScan SureStep® Glucose (Normal) Control Solution
Streck Laboratories Sugar-Chex® Linearity kit
Submission Summary (Full Text)
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SureStep®Pro Glucose Control /Linearity Solutions
510(k) Notification
K971014
APR 23 1997
# 510(k) Summary
## Summary of Safety and Effectiveness
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Judy Martin, RAC |
| --- | --- |
| Date | March 18, 1997 |
| Proprietary Name | LifeScan SureStep®Pro Glucose Control Solutions (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.
LifeScan, Inc.
CONFIDENTIAL
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SureStep®Pro Glucose Control /Linearity Solutions
510(k) Notification
# 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.
LifeScan, Inc.
CONFIDENTIAL
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