(109 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that measures electrical current. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a blood glucose monitoring system, intended for measuring glucose levels to aid in monitoring diabetes control, not for treating or preventing a disease.
No
The "Intended Use / Indications for Use" states that the device "is not to be used for the diagnosis of or screening of diabetes". Instead, it is an "aid to monitor the effectiveness of diabetes control."
No
The device description explicitly lists hardware components including a blood glucose meter, test strips, control solutions, lancing device, and sterile lancets.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The OneTouch® Verio® Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The OneTouch® Verio® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be shared.
The OneTouch® Verio® Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The OneTouch® Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
Product codes
NBW, LFR
Device Description
The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by a single patient, by people with diabetes at home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The OneTouch® Verio® Blood Glucose Monitoring System (meter, strips, and control solutions) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability, intermediate precision and linearity testing. A user performance evaluation assessed accuracy of results and usability of the device in the hands of intended users. The OneTouch® Verio® Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Accuracy Results for 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
K13/363
510(k) Summary
(as required by section 807.92(c).)
| Sponsor | LifeScan Europe, a Div. of Cilag GmbH International
Gubelstrasse 34
Zug, Switzerland 6300 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Oyinkan Donaldson,
Regulatory Affairs Manager
LifeScan Scotland Ltd
Beechwood Business Park North
Inverness, Scotland IV2 3ED
United Kingdom
Phone: +44(0) 1463 721259
Mobile: 44 (0) 7909 935151
Fax: 44 01463 722000
Email: odonalds@its.jnj.com |
| 510(k) Author | Fiona Leeper,
Senior Regulatory Affairs Specialist
LifeScan Scotland Ltd.
Beechwood Park North
Inverness, IV2 3ED, UK |
| Date Prepared | 9th May 2013 |
| Device Trade Name | OneTouch Verio Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| Classification | OneTouch Verio Blood Glucose Meters and
OneTouch Verio Test Strips are Class II devices (21
CFR § 862.1345), Product Code NBW, LFR |
| System Description | The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. |
| Predicate Device | OneTouch® Verio® IQ Blood Glucose Monitoring System (K110637, cleared on Sept 07, 2011) |
| Intended Use/Indications for Use | The OneTouch Verio® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be shared.
The OneTouch Verio® Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The OneTouch Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips. |
| Comparison to Predicate Device | The Subject device is different from the predicate device for the following aspects: |
| | Meter: ergonomic/physical design, user interface, hardware, electronic and software changes. There are no changes to the OneTouch® Verio® Test Strips or the OneTouch® Verio® Level 3 and Level 4 Control Solutions as a result of this 510(k) submission. |
| Technological Characteristics | There have been no changes to the intended use, operating principle or scientific technology.
There has been no change to the fundamental scientific technology, which is amperometric detection. The operating principle remains electrochemical reaction. |
| Summary of Performance
Characteristics | The OneTouch® Verio® Blood Glucose Monitoring System (meter, strips, and control solutions) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability, intermediate precision and linearity testing. A user performance evaluation assessed accuracy of results and usability of the device in the hands of intended users. The OneTouch® Verio® Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI). |
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System Accuracy
A comparison of system accuracy performance demonstrated that the OneTouch® Verio® Blood Glucose Monitoring System and the OneTouch® Verio®IQ Blood Glucose Monitoring System are substantially equivalent.
System Accuracy Results for Glucose Concentrations