(182 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that measures electrical current. There is no mention of AI, ML, or any complex data processing beyond basic measurement and comparison to reference values.
No.
This device is an in vitro diagnostic device used for monitoring blood glucose levels, not for providing therapy or treatment.
No
The device is explicitly stated as "not to be used for the diagnosis of or screening of diabetes". It is an aid to monitor the effectiveness of diabetes control for people already diagnosed with diabetes, which is a monitoring function, not a diagnostic one.
No
The device description explicitly states that the system consists of hardware components including a blood glucose meter, test strips, control solutions, lancing device, and sterile lancets, in addition to any potential software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "OneTouch Verio Flex™ 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 Flex™ 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 fingertip. The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared.
OneTouch Verio Flex™ 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 Flex™ 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 Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The OneTouch Verio Flex Blood Glucose Monitoring System consists of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Flex 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 (capillary whole blood samples)
Indicated Patient Age Range
Not to be used for neonatal use.
Intended User / Care Setting
Single patient, self testing 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
Method Comparison Performance: A study evaluating the glucose values from the OneTouch Verio Flex Blood Glucose monitoring System (obtained by healthcare professional fingersick samples from diabetic subjects) and compared to the glucose results obtained by the recognized glucose reference method (YSL 2300) from 115 subjects.
Lay User Performance Evaluation: Glucose values from fingertip capillary blood samples obtained by 172 lay persons.
Precision (Repeatability): 300 Venous Blood Samples Tested per glucose level.
Total Precision (Intermediate Precision): 600 Control Solution Tests.
System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3: A study was conducted to evaluate glucose values from fingertip capillary blood samples obtained by healthcare professionals from 100 subjects in accordance with the glucose ranges required by ISO15197:2013 Clause 6.3.5.
User Performance Evaluation in compliance with ISO 15197:2013(E) Clause 8: Glucose values from fingertip capillary blood samples obtained by 167 lay persons.
Annotation Protocol: The reference method used for all accuracy studies was the Yellow Springs Instrument (YSI) analyzer (specifically YSI 2300 STAT PLUS glucose analyzer as mentioned in some sections).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical performance testing, user performance evaluation, method comparison, precision (repeatability), total precision (intermediate precision), system accuracy in compliance with ISO 15197:2013(E) Clause 6.3, and user performance evaluation in compliance with ISO 15197:2013(E) Clause 8.
Sample Size:
- Method Comparison Performance: 115 subjects.
- Lay User Performance Evaluation: 172 lay persons.
- Precision (Repeatability): 300 venous blood samples per glucose level.
- Total Precision (Intermediate Precision): 600 control solution tests.
- System Accuracy (ISO 15197:2013 Clause 6.3): 100 subjects.
- User Performance Evaluation (ISO 15197:2013 Clause 8): 167 lay persons.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- Analytical performance testing included system accuracy, repeatability, intermediate precision and linearity testing.
- User performance evaluation assessed accuracy of results and usability of the device in the hands of intended users.
- The OneTouch Verio Flex Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI).
- Method Comparison Performance (N=115):
- 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are depicted in black and white. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
LIFESCAN EUROPE ALISON WILSON REGULATORY AFFAIRS PROJECT MANAGER BEECHWOOD PARK NORTH INVERNESS IV2 3ED, GREAT BRITAIN
Re: K150214
Trade/Device Name: One Touch Verio Flex™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: June 25, 2015 Received: July 02, 2015
Dear Alison Wilson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150214
Device Name
OneTouch Verio FlexTM Blood Glucose Monitoring System
Indications for Use (Describe)
The OneTouch Verio Flex™ 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 fingertip. The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared.
OneTouch Verio Flex™ 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 Flex™ 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 Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe on the left side and a blue swoosh above the text "LIFESCAN". Below the text, in a smaller, red font, it says "a Johnson & Johnson company". The logo is clean and professional, representing a well-established brand in the healthcare industry.
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
510(k) Summary (as required by section 807.92(c))
| Sponsor | LifeScan Europe, a Division of Cilag GmbH International
Gubelstrasse 34
Zug, Switzerland 6300 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Alison Wilson, Regulatory Affairs Project Manager
LifeScan Scotland Ltd.
Beechwood Park North
Inverness, IV2 3ED
United Kingdom
Phone: +44(0) 1463 721256
e-mail: awilson4@its.jnj.com
Alternate 510(k) Contact:
Oyinkan Donaldson, Senior Regulatory Affairs Manager
LifeScan Scotland Ltd
Beechwood Park North
Inverness, IV2 3ED
United Kingdom
Phone: +44 01463 721259
Mobile: +44 (0) 7909935151
Fax: +44 (0)1463 722000
e-mail: odonalds@its.jnj.com |
| Date Prepared | May 2015 |
| Device Trade Name | OneTouch Verio Flex Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
LifeScan Europe, a Div. of Cilag GmbH International
Page 1 of 13
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
4
Image /page/4/Picture/0 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in large, bold, blue letters. Below the company name is the text "a Johnson & Johnson company" in a smaller, red font. To the left of the company name is a blue globe and a curved blue line above the company name.
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
| Classification | OneTouch Verio Flex™ Blood Glucose Meters and OneTouch Verio™
Test Strips are Class II devices (21 CFR § 862.1345), Product Code
NBW, LFR
OneTouch Verio™ Control Solutions are Class I devices (21 CFR
§862.1660), Product Code JJX
Lancing Device and Sterile Lancets are Class I (exempt) devices (21
CFR § 878.4800), Product Code FMK | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| System Description | The OneTouch Verio Flex Blood Glucose Monitoring System consists
of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio®
Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions,
Lancing Device and Sterile Lancets. The OneTouch Verio Flex 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 (K131363,
Cleared 30th August 2013) | |
| Intended
Use/Indications for
Use | The OneTouch Verio Flex 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 fingertip. The
OneTouch Verio Flex Blood Glucose Monitoring System is intended to
be used by a single patient and should not be shared.
OneTouch Verio Flex 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 Flex 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 Flex Blood Glucose Meter to quantitatively measure glucose
drawn from the fingertips. | | |
| Comparison to
Predicate Device | The Subject device is different from the predicate device in the
following aspects:
• Meter:
○ Ergonomic/physical design: Changes to size, shape and color
○ Electronic/hardware: Strip port connector
○ Software/Firmware changes: Modified Blood Glucose
Algorithm and addition of a range indicator software feature.
• Labelling:
○ New branding and Instructions for Use
There are no changes to the OneTouch® Verio® Test Strips or the
OneTouch® Verio® Level 3 (Mid) and Level 4 (High) Control Solutions
cleared for use with the predicate OneTouch® Verio™ Blood Glucose
Monitoring System 510(k) (K131363).
There have been no changes to the intended use, operating principle or
scientific technology. | |
| 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
Characteristics | The OneTouch Verio Flex Blood Glucose Monitoring System (meter,
strips, and control solutions) was designed and tested in accordance with
ISO 15197:2013(E). Analytical performance testing included system | |
| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
| 77.8% | 100% | 100% |
| (42/54) | (54/54) | (54/54) |
LifeScan Europe, a Div. of Cilag GmbH International
Page 2 of 13
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
5
Image /page/5/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the company name, in smaller red font, is the text "a Johnson & Johnson company".
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
LifeScan Europe, a Div. of Cilag GmbH International
Page 3 of 13
Confidential and Proprietary Information
Part 2 510K Summary
Traditional 510(k)
6
Image /page/6/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the company name, in smaller red cursive font, is the text "a Johnson & Johnson company".
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
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 Flex Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI).
Method Comparison Performance
A study evaluating the glucose values from the OneTouch Verio Flex Blood Glucose monitoring System (obtained by healthcare professional fingersick samples from diabetic subjects) and compared to the glucose results obtained by the recognized glucose reference method (YSL 2300) from 115 subjects showed the following results:
NOTE: first test sample data is presented here.
Method Comparison Results for Glucose Concentrations 75mg/dL
LifeScan Europe, a Div. of Cilag GmbH International
Page 6 of 13
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
9
Image /page/9/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the word "LIFESCAN" is the phrase "a Johnson & Johnson company" in smaller, red letters. A blue swoosh appears above the globe and the word "LIFESCAN".
Lay User Performance Evaluation
A study to validate the accuracy performance of the OneTouch Verio Flex Blood Glucose Monitoring System in the hands of the user was undertaken. A comparison of the Lay User OneTouch Verio Flex Blood Glucose Monitoring System fingertip results compared to glucose results obtained on the recognized glucose reference method (YSI 2300 STAT PLUS glucose analyzer), are summarized below. Glucose values from fingertip capillary blood samples obtained by 172 lay persons showed the following results:
Subject Fingertip Results for Glucose Concentrations Confidential and Proprietary Information |
| Traditional 510(k) | OneTouch Verio FlexTM Blood Glucose Monitoring System |
10
Image /page/10/Picture/0 description: The image shows the LifeScan logo, which features the company name in bold, blue letters. Above the name is a blue swoosh, and to the left is a blue globe. Below the company name, in smaller, red cursive letters, is the text "a Johnson & Johnson company."
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
| Target Glucose | Mean Glucose | Standard Deviation | Coefficient of |
|---|---|---|---|
| (mg/dL) | (mg/dL) | (mg/dL) | Variation (%) |
| 20 | 18.3 | 0.63 | 3.43 |
| 40 | 36.5 | 0.83 | 2.26 |
| 90 | 88.5 | 1.72 | 1.95 |
| 130 | 127.9 | 2.50 | 1.95 |
| 200 | 199.3 | 3.94 | 1.98 |
| 350 | 344.6 | 6.18 | 1.79 |
| 600 | 583.4 | 10.54 | 1.81 |
Results show that the greatest variability observed between test strips when tested with blood is 1.72mg/dl SD or less at glucose levels less than 100mg/dl, or 1.98% or less at glucose levels at 100mg/dl or above
Total Precision (Intermediate Precision)
(600 Control Solution Tests)
| Glucose Level
Ranges
(mg/dL) | Mean Glucose
(mg/dL) | Standard Deviation
(mg/dL) | Coefficient of
Variation (%) |
|------------------------------------|-------------------------|-------------------------------|---------------------------------|
| Very Low (0-24) | 12.46 | 0.57 | 4.54 |
| Low (25 - 49) | 37.14 | 0.92 | 2.48 |
| Mid (102 - 138) | 117.68 | 2.41 | 2.05 |
| High (298 – 403) | 348.99 | 8.31 | 2.38 |
| Very High (446-604) | 515.18 | 13.53 | 2.63 |
LifeScan Europe, a Div. of Cilag GmbH International
Page 8 of 13
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
11
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System Accuracy performance in accordance with ISO 15197:2013(E)
Accuracy of the subject device was analysed and assessed in compliance with the product design requirements in accordance with the requirements of ISO 15197:2013(E) Clause 6.3 System Accuracy and Clause 8 User Performance Evaluation.
System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3:
A study was conducted to evaluate glucose values from fingertip capillary blood samples obtained by healthcare professionals from 100 subjects in accordance with the glucose ranges required by ISO15197:2013 Clause 6.3.5. The analysis showed the following results: 100% for all 3 test strip lots within ±15mg/dl of the medical laboratory values at glucose concentrations below 100mg/dL and 99.3%, 100%, 98.7% within ±15% of the medical laboratory values at glucose concentrations at or above 100mg/dL.
System Accuracy Results for Glucose Concentrations Confidential and Proprietary Information |
| Traditional 510(k) | OneTouch Verio Flex™ Blood Glucose Monitoring System |
13
Image /page/13/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the word "LIFESCAN" is the text "a Johnson & Johnson company" in a smaller, red, cursive font. A blue swoosh design arches over the globe and the word "LIFESCAN".
Division of Cilag GmbH International Gubelstrasse 34 , CH-6300 Zug, Switzerland
A study to validate the accuracy performance of the OneTouch Verio Flex Blood Glucose Monitoring System in the hands of the Lay user in accordance with ISO 15197:2013(E) Clause 8 was undertaken. A comparison of the Lay User OneTouch Verio Flex Blood Glucose Monitoring System fingertip results compared to glucose results obtained on the recognized glucose reference method (YSI 2300 STAT PLUS glucose analyzer), are summarized below:
Glucose values from fingertip capillary blood samples obtained by 167 lay persons showed the following results:
93.1% within ±15mg/dl of the glucose reference (YSI) values at glucose concentrations below 100mg/dL and 98.6% within ±15% of the medical laboratory values at glucose concentrations at or above 100mg/dL.
97.6% of the total number of samples across the entire glucose range were within ±15 mg/dl or ±15% of the medical laboratory values.