(34 days)
LifeScan SureStep® Glucose (Normal) Control Solution
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No
The device description and intended use clearly describe a glucose control and linearity test solution, which are chemical reagents used to verify the performance of a blood glucose meter. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
This device is a control and linearity testing solution for verifying the performance of a blood glucose meter, not a therapeutic device used to treat a medical condition.
No
The device is described as a "quality control material for verification of System performance" and for "verification of System linearity" for blood glucose meters. This indicates it is used to check the accuracy and proper functioning of another device (the blood glucose meter), rather than directly diagnose a patient's condition.
No
The device description clearly indicates the product is a liquid solution containing glucose, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the solutions are for "verification of System performance" and "verification of System linearity" when used with blood glucose meters and test strips. This indicates they are used in vitro (outside the body) to assess the performance of a diagnostic system.
- Device Description: The description explains that the solutions contain a measured amount of glucose that reacts with the test strips, and the results are used to determine if the system is performing correctly or to verify linearity. This is a classic function of an IVD control or linearity material.
- Predicate Devices: The listed predicate devices are "LifeScan SureStep® Glucose (Normal) Control Solution" and "Streck Laboratories Sugar-Chex® Linearity kit." These are known examples of IVD control and linearity materials.
Therefore, the SureStep®Pro Glucose Control Solutions and Linearity Test Kit fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
LifeScan SureStep® Glucose (Normal) Control Solution
Reference Device(s)
Streck Laboratories Sugar-Chex® Linearity kit
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
KG71014
510(k) Summary Summary of Safety and Effectiveness
APR
23 1997
| 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.
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.
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