(88 days)
LifeScan SureStep® Blood Glucose Monitoring System, LifeScan ONE TOUCH® II 24ospital Blood Glucose Monitoring System
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No
The summary describes a standard blood glucose monitoring system using a reflectance photometer and test strips, with no mention of AI or ML terms or functionalities.
No
The device is intended for the quantitative measurement of glucose, which is a diagnostic function, not a therapeutic one. It monitors a condition rather than treating or preventing it.
Yes
The device is a blood glucose monitoring system, which measures glucose levels in blood. This measurement provides information that can be used to diagnose or monitor conditions like diabetes.
No
The device description explicitly lists hardware components: a glucose reagent test strip, a reflectance photometer, and quality control solutions.
Yes, based on the provided information, the LifeScan SureStepPro blood glucose monitoring system is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states "quantitative measurement of glucose in a sample of whole blood." This involves testing a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
- Device Description: The device consists of a "glucose reagent test strip" and a "reflectance photometer." These are components typically used in in vitro diagnostic testing to analyze a sample and produce a result.
- Nature of the Test: Measuring glucose in blood is a classic example of an in vitro diagnostic test used to assess a patient's health status, particularly for conditions like diabetes.
The fact that it can be used in both clinical settings and by lay persons at home further reinforces its nature as a device used for diagnostic purposes on biological samples.
N/A
Intended Use / Indications for Use
The LifeScan SureStepPro blood glucose monitoring system is intended for quantitative measurement of glucose in a sample of whole blood. It can be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates. It can also be used by lay persons for capillary blood glucose monitoring in the home.
Product codes
75CGA
Device Description
The SureStepPro blood glucose monitoring system consists of a qlucose reagent test strip, a reflectance photometer, and quality control solutions. A data management system for hospital tracking of patient and quality control information will also be available.
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
adults and neonates
Intended User / Care Setting
lay persons for capillary blood glucose monitoring in the home, clinical setting
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
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Key Metrics
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Predicate Device(s)
LifeScan SureStep® Blood Glucose Monitoring System, LifeScan ONE TOUCH® II 24ospital Blood Glucose Monitoring System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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LifeScan Inc. SureStep®Pro blood glucose monitoring system 510(k) Submission
MAY 12 1997
510(k) Summary Summary of Safety and Effectiveness
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Judy Martin, RAC |
|---------------------|----------------------------------------------------------------------------------|
| Date | February 10, 1997 |
| Proprietary Name | LifeScan SureStep®Pro blood glucose monitoring system |
| Common name | Blood glucose monitor |
| Classification name | 75CGA: glucose oxidase,
glucose test system |
Device description
The SureStepPro blood glucose monitoring system consists of a qlucose reagent test strip, a reflectance photometer, and quality control solutions. A data management system for hospital tracking of patient and quality control information will also be available.
Intended Use
The LifeScan SureStepPro blood glucose monitoring system is intended for quantitative measurement of glucose in a sample of whole blood. It can be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates. It can also be used by lay persons for capillary blood glucose monitoring in the home.
Substantial Equivalence
The LifeScan SureStepPro blood glucose monitoring system is substantially equivalent to the currently marketed LifeScan SureStep® Blood Glucose Monitoring System and the LifeScan ONE TOUCH® II 24ospital Blood Glucose Monitoring System.