(336 days)
Not Found
No
The description focuses on electrochemical measurement and standard performance metrics, with no mention of AI or ML.
No.
The device is an in vitro diagnostic device used to measure glucose levels, aiding in the monitoring of diabetes control. It does not directly provide therapy or treatment.
No
The device is described as an "aid to monitor the effectiveness of diabetes control" and explicitly states that it "should not be used for the diagnosis of or screening of diabetes".
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 Sync BGMS 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 Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared.
The OneTouch Verio Sync BGMS 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 Sync BGMS should not 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 Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The OneTouch® Verio™ Sync 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™ Sync 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
Home use by people with diabetes; self-testing
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™ Sync 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™ Sync 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
(510(k) Summary (as required by section 807.92(c).
FEB 7 2013
| Sponsor | LifeScan Europe, a Division of Cilag GmbH
International
Landis and Gyr Strasse 1
Zug, Switzerland 6300 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Nadine Nasr, Regulatory Project Manager
LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, California 95035
Phone: 408-956-4079, 408-942-5906
Email: nnasr@its.jnj.com
Alternate 510(k) Contact:
Yvonne Middlefell, Director Regulatory Affairs
LifeScan Scotland Ltd
Beechwood Business Park North
Inverness, Scotland IV2 3ED
United Kingdom
Phone: 44 01463 721250
Mobile: 44 (0) 7900 138 650
Fax: 44 01463 722000
Email: ymiddlef@its.jnj.com |
| Date Prepared | 07th Feb 2013 |
| Device Trade Name | OneTouch Verio Sync Blood Glucose Monitoring
System |
| Common Name | Glucose Test System |
LifeScan Europe, a Div. of Cilag GmbH International
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| Classification | OneTouch Verio Sync 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™ Sync 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™ Sync 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 Blood Glucose Monitoring System
(K093745, cleared on February 11, 2011) | |
| Intended Use/Indications for Use | The OneTouch Verio Sync Blood Glucose
Monitoring System (BGMS) is intended to be used
for the quantitative measurement of glucose (sugar) in
fresh capillary whole blood samples drawn from the
fingertip. The system is intended to be used by a
single person and should not be shared.
The OneTouch Verio Sync BGMS 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 Sync BGMS should not 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 Sync Blood Glucose Meter to
quantitatively measure glucose (sugar) in fresh | |
| | capillary whole blood samples drawn from the fingertips. | |
| Comparison to Predicate Device | The Subject device is different from the predicate device for the following aspects:
• Meter: shape/size, ergonomic design,
simplified user interface, wireless communication with the OneTouch Reveal Diabetes Management Application and a rechargeable battery.
There have been no changes to the OneTouch® Verio™ Test Strip principle of operation, materials of construction, design of strip or electrodes, and they are identical to the test strips in the OneTouch® Verio™ Blood Glucose Monitoring System, K093745. The OneTouch® Verio™ Control Solutions composition and functional performance are also the same as those cleared in the OneTouch® Verio™ Blood Glucose Monitoring System, K093745. However, changes were made to the labeling provided with those components of the system at the request of the Food and Drug Administration during review of the OneTouch Verio IQ 510(k) Submission, K110637. There are some differences in the intended use, specifically around alternate site testing and the removal of the indication for forearm or palm testing. The OneTouch Verio Sync Blood Glucose Monitoring System is not validated for alternate site testing. Only | |
| | fingertip testing is indicated for this system. | |
| Technological Characteristics | There has been no change to the fundamental scientific | |
| | technology, which is amperometric detection. The | |
| | operating principle remains electrochemical reaction. | |
| | | |
| Summary of Performance | The OneTouch® Verio™ Sync Blood Glucose | |
| Characteristics | 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™ Sync 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" Sync Blood Glucose Monitoring System and the OneTouch® Verio™ Blood Glucose Monitoring System are substantially equivalent.