(434 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 used to measure glucose levels as an aid to monitor diabetes control, not to treat or mitigate a disease.
No.
The device is explicitly stated as "should not be used for the diagnosis of or screening of diabetes". Instead, it serves as an aid to monitor the effectiveness of diabetes control.
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 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," which is the definition of an IVD. The device measures glucose in blood samples taken from the body, which is a classic example of an in vitro diagnostic test.
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, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
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 should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).
The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" 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
fingertips, forearm or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single patient, 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)
Analytical performance testing included system accuracy, repeatability and intermediate precision 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).
System Accuracy: A comparison of system accuracy performance demonstrated that the OneTouch® Verio" Blood Glucose Monitoring System and the currently marketed OneTouch® Ultra®2 Meter are substantially equivalent.
Regression Statistics: Samples were tested in duplicate on three test strip lots.
Precision:
Within Run Precision (300 Venous Blood Tests)
Target Glucose (mg/dL) | Mean Glucose (mg/dL) | Standard Deviation (mg/dL) | Coefficient of Variation (%)
40 | 39.37 | 1.07 | 2.72
100 | 100.58 | 1.75 | 1.74
130 | 126.12 | 2.41 | 1.91
200 | 189.24 | 3.36 | 1.78
350 | 323.63 | 6.65 | 2.05
Results show that the greatest variability observed between test strips when tested with blood is 2.72% or less.
Total Precision (600 Control Solution Tests)
Glucose Level Ranges (mg/dL) | Mean Glucose (mg/dL) | Standard Deviation (mg/dL) | Coefficient of Variation (%)
Low (38-62) | 50.66 | 1.28 | 2.53
Mid (102-138) | 116.51 | 2.89 | 2.48
High (298-403) | 350.02 | 7.7 | 2.2
User Performance Evaluation:
Subject and HCP Fingertip 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
093745
510(K) SUMMARY
| SPONSOR | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035 U.S.A. | FEB 11 2011 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CORRESPONDENT | Lisa McGrath
LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Phone: 408-956-4446/e-mail: lmcgrat2@its.jnj.com | |
| DEVICE NAME AND
CLASSIFICATION | 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)
OneTouch® Verio™ Control Solutions are Class I devices (21 CFR § 862.1660)
Product Code JJX | |
SYSTEM DESCRIPTION
The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" 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 DEVICES
OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529) OneTouch® Select™ Control Solutions (K072543)
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, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
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 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" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
1
510(K) SUMMARY, CONTINUED
The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
COMPARISON TO PREDICATE DEVICES
The Subject device is different from the predicate device for the following aspects:
- Meter: ergonomic/physical design, user interface, hardware, modified electronic and software ● changes.
- Test Strip: materials of construction, physical layout of the strip electrodes, enzyme chemistry, . calibration coding and sample application location.
- Control Solution: glucose nominal levels, composition and color of control solutions. .
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; however the Subject device uses Glucose Dehydrogenase and the predicate device uses Glucose Oxidase as the reagent.
SUMMARY OF PERFORMANCE CHARACTERISTICS
The OneTouch® Verio" Blood Glucose Monitoring System (meter, strips, and control) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability and intermediate precision 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).
System Accuracy
A comparison of system accuracy performance demonstrated that the OneTouch® Verio" Blood Glucose Monitoring System and the currently marketed OneTouch® Ultra®2 Meter are substantially equivalent.
System Accuracy Results for Glucose Concentrations Trade Name: One Touch Verio Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: February 8, 2011 Received: February 9, 2011
Dear Ms. McGrath:
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 enclosuré) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
5
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket 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 Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE FORM
510(k) Number (if known): _ K093745
OneTouch® Verio™ Blood Glucose Monitoring System Device Name: ____
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, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
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 should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).
The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
| Prescription Use
(Part 21 CFR 801
Subpart D) | AND/OR | Over-The-Counter Use X (21 CFR 801
Subpart C) |
| ---------------------------------------------------- | -------- | --------------------------------------------------------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093745