(155 days)
No
The summary describes a standard blood glucose monitoring system with added radio-frequency transmission capabilities, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) device used for monitoring glucose levels, not for providing therapy or treatment. Its intended use is as an aid to monitor the effectiveness of diabetes control, not to actively treat the condition.
Yes
The device is intended for "in vitro diagnostic use" for the quantitative measurement of glucose, and its purpose is to "monitor the effectiveness of diabetes control," which are characteristic functions of a diagnostic device.
No
The device description explicitly lists hardware components such as the blood glucose meter, test strips, control solution, lancing device, and lancets. While it includes software for data transmission, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm."
This statement clearly identifies the device as being used for testing biological samples (blood) outside of the body to diagnose or monitor a medical condition (diabetes), which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.
Product codes
NBW, CGA
Device Description
The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, forearm or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
people with diabetes in a home setting and by healthcare professionals in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
| Performance Characteristic | Test method employed | Results |
|---|---|---|
| Precision | ISO 15197:2003, Section 7.2 | The OneTouch® UltraLink™ Blood Glucose Monitoring System demonstrated acceptable system precision. |
| Accuracy | ISO 15197:2003 Section 7.3 (7.4) | Ninety-five percent (95 %) of the individual glucose results fell within ± 15 mg/dL of the results of the reference method at glucose concentrations |
§ 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.
0
APR 1 8 2008
510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92
| Submitted by: | LifeScan, Inc.
1000 Gibralter Ave.
Milpitas, CA. 95035 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kim Fonda
Senior Regulatory Affairs Specialist
Phone: (408) 942-3733
FAX: (408) 942-5906
E-Mail: kfonda@lfsus.jnj.com |
| Summary Date: | November 14, 2007 |
| Trade Name: | OneTouch ® UltraLink ™ Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Monitor |
| | Device Classification: Class II, Glucose Test System (21 CFR §862.1345, Product Code NBW) |
Substantial Equivalence
The OneTouch® UltraLink™Blood Glucose Monitoring System is substantially equivalent to the OneTouch® Ultra®2 Blood Glucose Monitoring System as cleared under K053529. Both devices have a similar intended use, measure the same sample type and have similar performance characteristics. The OneTouch® UltraLink™ Blood Glucose Monitoring System is substantially equivalent to the BD Paradigm Link® Blood Glucose Monitor as cleared under K040603 for the ability to transmit blood glucose results using Radio-Frequency telemetry.
Device Description
The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch®
1
UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.
Intended Use
The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for selftesting outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
| Predicate Device | Similarities to Subject Device | Differences between Subject
Device
(Modifications) |
|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| OneTouch® Ultra®2 Blood
Glucose Monitoring System
(K053529)
Quantitative measurement
of blood glucose | Same intended use
Same sample type
Same fundamental scientific
technology
Same system components | Meter: ergonomic/physical
design, electronic/hardware,
software/firmware.
Instructions for use - addition of
Radio Frequency use information |
| BD Paradigm Link® Blood
Glucose Monitor
(K040603)
Radio-Frequency
transmission of blood
glucose results. | Same fundamental scientific
technology
Equivalent radio-Frequency
protocol specifications | RF module contained in a
different blood glucose meter |
Technological Characteristics
Comparison with Predicate devices
2
Performance Summary
| Performance
| Characteristic | Test method employed | Results |
|---|---|---|
| Precision | ISO 15197:2003, | |
| Section 7.2 | The OneTouch® UltraLink™ Blood Glucose | |
| Monitoring System demonstrated acceptable | ||
| system precision. | ||
| Accuracy | ISO 15197:2003 | |
| Section 7.3 (7.4) | Ninety-five percent (95 %) of the individual | |
| glucose results fell within ± 15 mg/dL of the | ||
| results of the reference method at glucose | ||
| concentrations |