(182 days)
YSI 2300, YSI 2300 STAT PLUS glucose analyzer, YSI, YSI reference
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 the direct measurement of glucose.
No
The device is used to monitor blood glucose levels, which aids in managing diabetes, but it does not treat or cure the condition.
No
The document states, "The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes". This explicitly indicates it is not a diagnostic device for diabetes.
No
The device description explicitly states that the system consists of a meter, test strips, control solutions, lancing device, and lancets, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The OneTouch Ultra Plus 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."
N/A
Intended Use / Indications for Use
The OneTouch Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The OneTouch Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use.
The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus Flex Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
Product codes
NBW, LFR
Device Description
The OneTouch Ultra Plus Flex Blood Glucose Monitoring System consists of the OneTouch Ultra Plus Flex Blood Glucose Meter, OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Ultra Plus 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 (through capillary whole blood samples)
Indicated Patient Age Range
Not Found. Not to be used for neonatal use.
Intended User / Care Setting
self testing outside the body (in vitro diagnostic use) 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 Study:
- Sample Size: 113 subjects
- Data Source: Fresh capillary whole blood samples drawn from the fingertip of diabetic subjects (obtained by healthcare professionals).
- Annotation Protocol: Comparison to glucose results obtained by the recognized glucose reference method (YSI 2300).
Lay User Performance Evaluation:
- Sample Size: 169 lay persons (Lay User performance evaluation on page 8), 166 lay persons (User Performance Evaluation in accordance with ISO 15197:2013(E) Clause 8 on page 15).
- Data Source: Fingertip capillary blood samples.
- Annotation Protocol: Comparison to glucose results obtained on the recognized glucose reference method (YSI 2300 STAT PLUS glucose analyzer).
Precision (Repeatability) Study:
- Sample Size: 300 Venous Blood Samples Tested per glucose level.
- Data Source: Venous blood samples.
- Annotation Protocol: Not explicitly stated, implied by repeating measurements to assess within-run precision.
Total Precision (Intermediate Precision) Study:
- Sample Size: 600 Control Solution Tests.
- Data Source: Control solutions.
- Annotation Protocol: Not explicitly stated, implied by repeated testing of control solutions to assess intermediate precision.
System Accuracy performance in accordance with ISO 15197:2013(E) Clause 6.3:
- Sample Size: 100 subjects.
- Data Source: Fingertip capillary blood samples obtained by healthcare professionals.
- Annotation Protocol: Comparison to medical laboratory values (YSI reference) in accordance with glucose ranges required by ISO15197:2013 Clause 6.3.5.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Analytical Performance Testing (interference, system accuracy, repeatability, intermediate precision, linearity testing), User Performance Evaluation.
- Sample Size:
- Method Comparison Performance: 113 subjects
- Lay User Performance: 169 lay persons / 166 lay persons
- Precision (Repeatability): 300 Venous Blood Samples Tested per glucose level
- Total Precision (Intermediate Precision): 600 Control Solution Tests
- System Accuracy (ISO 15197:2013(E) Clause 6.3): 100 subjects
- Standalone Performance: The OneTouch Ultra Plus Flex Blood Glucose Monitoring System performed similarly to both the predicate device and a laboratory reference method, the Yellow Springs Instrument (YSI).
- Key Results:
- Method Comparison Performance (Healthcare Professional samples vs. YSI):
- Glucose Concentrations
- Method Comparison Performance (Healthcare Professional samples vs. YSI):
§ 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
LIFESCAN EUROPE NIKI SKELLY REGULATORY AFFAIRS CONSULTANT BEECHWOOD PARK NORTH INVERNESS, SCOTLAND IV2 3ED, GREAT BRITAIN
Re: K151611
Trade/Device Name: OneTouch Ultra Plus Flex Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: November 17, 2015 Received: November 20, 2015
Dear Niki Skelly:
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,
Katherine Serrano -S
For: 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) K151611
Device Name
OneTouch Ultra Plus Flex Blood Glucose Monitoring System
Indications for Use (Describe)
The OneTouch Ultra Plus 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 One Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared.
OneTouch Ultra Plus 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 One Duch Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use.
The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus 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)
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3
Image /page/3/Picture/0 description: The image shows the LifeScan logo. The logo features a blue arc over the word "LIFESCAN" in blue, block letters. Below the company name is the phrase "a Johnson & Johnson company" in a cursive, red font. To the left of the company name is a blue globe.
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 | Niki Skelly, Regulatory Affairs Consultant
LifeScan Scotland Ltd.
Beechwood Park North
Inverness, IV2 3ED
United Kingdom
Phone: +44(0) 1463 721652
Mobile : +44(0) 7818 523098
e-mail: nskelly@its.jnj.com
Alternate 510(k) Contact:
Alison Wilson, Regulatory Affairs Project Manager
LifeScan Scotland Ltd
Beechwood Park North
Inverness, IV2 3ED
United Kingdom
Phone: +44 01463 721256
Mobile: +44 (0) 7900 168332
Fax: +44 (0)1463 722000
e-mail: awilson4@its.jnj.com |
| Date Prepared | December 11th 2015 |
| Device Trade Name | OneTouch Ultra Plus Flex Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| Classification | OneTouch Ultra Plus Flex Blood Glucose Meters and OneTouch Ultra
Plus Test Strips are Class II devices (21 CFR § 862.1345), Product
Code NBW, LFR |
| System Description | The OneTouch Ultra Plus Flex Blood Glucose Monitoring System
consists of the OneTouch Ultra Plus Flex Blood Glucose Meter,
OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and
Level 4 Control Solutions, Lancing Device and Sterile Lancets. The |
| | OneTouch Ultra Plus 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 Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System is
intended to be used by a single patient and should not be shared.
The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is
intended for self testing outside the body (in vitro diagnostic use) bydiabetes control. The OneTouch Ultra Plus Flex Blood Glucose
Monitoring System is not to be used for the diagnosis of or screening of
diabetes, or for neonatal use.
The OneTouch Ultra Plus Test Strips are for use with the OneTouch
Ultra Plus 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: Modified Strip Port Connector and
addition of wireless communications facility
• Software/Firmware changes: Modified Blood Glucose
Algorithm and addition of a range indicator software feature
• Labelling: |
| | New branding and Instructions for Use for Meter, Test Strips
and Control Solutions |
| | Strip: |
| | Change to color of spacer layer |
| | Laser line on left strip leg to align with new Strip Port
Connector |
| | The only change to the Control Solutions cleared for use with the
predicate OneTouch® Verio™ Blood Glucose Monitoring System 510(k)
(K131363) as OneTouch Verio Control Solutions Level 3 (Mid) and
Level 4 (High) is that a new brand name of OneTouch Ultra Plus Level
3 (Mid) and Level 4 (High) Control Solutions will be used to align
branding with the new system; the formula is identical to the cleared
Control Solution. The OneTouch Verio Control Solutions will continue
to be marketed with the associated cleared BGMS. |
| | 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 Ultra Plus 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 interference, 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 Ultra Plus Flex Blood Glucose Monitoring
System performed similarly to both the predicate device and a
laboratory reference method, the Yellow Springs Instrument (YSI). |
LifeScan Europe, a Div. of Cilag GmbH International
Page 1 of 15
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
4
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Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
LifeScan Europe, a Div. of Cilag GmbH International
Page 2 of 15
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
5
Image /page/5/Picture/0 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in large, bold, blue letters. Above the word is a blue swoosh and a blue globe. Below the word is the text "a Johnson & Johnson company" in a smaller, red font.
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
LifeScan Europe, a Div. of Cilag GmbH International
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
6
Image /page/6/Picture/0 description: The image is the logo for LifeScan, a Johnson & Johnson company. The logo features a blue swoosh design above a globe graphic on the left. The text "LIFESCAN" is written in large, bold, blue letters, and below it, in a smaller, cursive, red font, is the text "a Johnson & Johnson company".
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
Interference Performance
The maximum allowed concentration of every potentially interfering substance was tested in a study (i.e. the highest concentration tested that would not compromise system response of the OneTouch Ultra Plus Flex System). Samples with 2 levels of glucose 70 and 300mg/dL were tested by spiking with potentially interfering substances at 4 concentrations, each sample was analyzed by the OneTouch Ultra Plus Flex meter. Test results of the spiked samples were compared with results from control samples without potential interfering substances and the difference between the 2 samples was calculated. The results in the table below are within ≤10% of the control sample.
| Interferent | Maximum
Allowed
Concentration
(mg/dL) | Does the Maximum Allowed
Concentration exceed the High
Normal/Therapeutic
Endogenous Concentration? |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acetaminophen | 10.892 | Yes |
| Ascorbic Acid | 6.38 | Yes |
| Bilirubin | 20.53 | Yes |
| Cholesterol | 794.4 | Yes |
| Creatinine | 31.83 | Yes |
| Dopamine | 0.0512 | Yes |
| EDTA | 0.10 | Yes |
| Ephedrine | 0.21 | Yes |
| Galactose | 60.39 | Yes |
| Gentisic Acid | 1.85 | Yes |
| Glutathione | 92.61 | Yes |
| Haemoglobin | 237.6 | Yes |
| Heparin | 2.15 | Yes |
| Ibuprofen | 50.52 | Yes |
| Icodextrin | 1241.72 | Yes |
| Interferent | Maximum
Allowed
Concentration
(mg/dL) | Does the Maximum Allowed
Concentration exceed the High
Normal/Therapeutic
Endogenous Concentration? |
| Lactose | 4.25 | Yes |
| L-Dopa (Levo-Dopa) | 1.01 | Yes |
| Maltose | 363.60 | Yes |
| M-Dopa (Methyl-Dopa) | 1.50 | Yes |
| Pralidoxime Iodide (PAM) | OneTouch Ultra
Plus Flex Blood
Glucose
Monitoring
system not to be
used with
patients
undergoing
PAM treatment | No
OneTouch Ultra Plus Flex
SMBG system is not to be used
with patients undergoing PAM
treatment: Caution included in
product labelling4 |
| Salicylic Acid | 58.90 | Yes |
| Tetracycline | 1.52 | Yes |
| Tolazamide | 15.03 | Yes |
| Tolbutamide | 65.98 | Yes |
| Triglycerides | 3431.11 | Yes |
| Urea | 297.55 | Yes |
| Uric Acid | 8.11 | Yes |
| Interferent | Maximum
Allowed
Concentration
(mg/dL) | Does the Maximum Allowed
Concentration exceed the High
Normal/Therapeutic
Endogenous Concentration? |
| Xylose | 8.09 | No
OneTouch Ultra Plus Flex
SMBG system is not to be used
with patients undergoing xylose
absorption treatment:
Caution included in product
labelling 3 |
LifeScan Europe, a Div. of Cilag GmbH International
Page 4 of 15
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
7
Image /page/7/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe on the left side. To the right of the globe is the company name, "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
LifeScan Europe, a Div. of Cilag GmbH International
Page 5 of 15
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
8
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LifeScan
Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
Based on the results in this table, interferent limitations identified in labeling are noted below 1 2 3 4 ップ クリッ
1 Uric acid at concentrations greater than 8mg/dL can interfere with glucose measurements.
2 Drugs containing acetaminophen (e.g Tylenol etc.) or Dopamine at doses higher than the recommended high therapeutic level, may result in inaccurate readings from the OneTouch Ultra Plus Flex™ blood glucose monitoring system.
3 The OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System should not be used within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results.
4 The OneTouch Ultra Plus Flex™ Meter should not be used when PAM (Pralidoxime) is known or suspected to be in the whole blood sample.
LifeScan Europe, a Div. of Cilag GmbH International
Page 6 of 15
Part 2 510K Summary
Confidential and Proprietary Information
Traditional 510(k)
9
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LifeScan Division of Cilag GmbH International Gubelstrasse 34 , CH-6300 Zug, Switzerland
Method Comparison Performance
A study evaluating the glucose values from the OneTouch Ultra Plus 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 (YSI 2300) from 113 subjects showed the following results: NOTE: first test sample data is presented here.