(187 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. The performance studies focus on analytical accuracy and user performance, not on the evaluation of an AI/ML algorithm.
No.
The device is an in vitro diagnostic (IVD) device used for monitoring glucose levels, not for treating a medical condition.
No
The text explicitly states: "The OneTouch® Verio™ "IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use." It is intended for monitoring diabetes, not diagnosing it.
No
The device description explicitly lists multiple hardware components including the glucose meter, test strips, control solutions, lancing device, and lancets.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"OneTouch® Verio" IQ 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® Verio"TQ 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" IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
OneTouch® Verio" 10 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™ VQ 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 rapidly).
The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio""IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips, forearm or palm.
The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" IQ Blood Glucose Meter and the OneTouch® Verio" 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, IIX
Device Description
The OneTouch® Verio" Verio" IQ Blood Glucose Monitoring System consists of the OneTouch Verio" " Q Blood Glucose Meter, OneTouch® Verio" Test Strips, OneTouch® Verio" Mid and High Control Solutions, Lancing Device, Sterile Lancets and Alternative Site testing Kit (available separately). The Alternative Site Testing Kit comprises the OneTouch® Lancing Device, OneTouch® UltraSoft" Sterile Lancets, OneTouch®, Clear Cap and Instructions for Use. The OneTouch® Verio" IQ 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
Fingertips, forearm, palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
People with diabetes at home, for 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" IQ 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 The OneTouch® Verio""IQ Blood Glucose Monitoring System performed intended users. 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" [Q Blood Glucose Monitoring System and the OneTouch® Verio" Blood Glucose Monitoring System are substantially equivalent.
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 | SEP - 7 201 |
|---|---|
| SPONSOR | LifeScan Europe, a Div. of Cilag GmbH International |
| Landis and Gyr Strasse 1 | |
| Zug, Switzerland 6300. | |
| CORRESPONDENT | Fiona Leeper |
| LifeScan Scotland Ltd. | |
| Beechwood Park North | |
| Inverness, IV2 3ED, UK | |
| Phone: +44(0) 1463 721596 /e-mail: fleeper@its.jnj.com | |
| Alternate 510(K) Contact | |
| Amy Smith | |
| 200 Lawrence Drive | |
| West Chester | |
| PA, 19380 | |
| Phone: +1 484 568-1257/e-mail: asmith21@its.jnj.com | |
| DEVICE NAME | |
| AND | |
| CLASSIFICATION | Trade Name: OneTouch® Verio™IQ Blood Glucose Monitoring System |
| Common name: Glucose Test System | |
| Classification: | |
| OneTouch® Verio™IQ 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 IIX |
SYSTEM DESCRIPTION
The OneTouch® Verio" Verio" IQ Blood Glucose Monitoring System consists of the OneTouch Verio" " Q Blood Glucose Meter, OneTouch® Verio" Test Strips, OneTouch® Verio" Mid and High Control Solutions, Lancing Device, Sterile Lancets and Alternative Site testing Kit (available separately). The Alternative Site Testing Kit comprises the OneTouch® Lancing Device, OneTouch® UltraSoft" Sterile Lancets, OneTouch®, Clear Cap and Instructions for Use. The OneTouch® Verio" IQ 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.
1
PREDICATE DEVICE
OneTouch® Verio™ Blood Glucose Monitoring System (K093745)
INTENDED USE/INDICATIONS FOR USE
The OneTouch® Verio"TQ 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" IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
OneTouch® Verio" 10 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™ VQ 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 rapidly).
The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio""IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips, forearm or palm.
The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" IQ Blood Glucose Meter and the OneTouch® Verio" Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly ..
COMPARISON TO PREDICATE DEVICE
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.
There are no changes to the OneTouch® Verio™ Test Strips or the OneTouch® Verio™ Mid and High Control Solutions as a result of this 510k submission.
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.
2
510(K) SUMMARY, CONTINUED
SUMMARY OF PERFORMANCE CHARACTERISTICS
The OneTouch® Verio" IQ 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 The OneTouch® Verio""IQ Blood Glucose Monitoring System performed intended users. 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" [Q Blood Glucose Monitoring System and the OneTouch® Verio" Blood Glucose Monitoring System are substantially equivalent.
System Accuracy Results for Glucose Concentrations Re: K110637 Trade Name: OneTouch® Verio™ IQ Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR. NBW Dated: August 19, 2011 Received: August 24, 2011
Dear Ms. Leeper:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/def.ault.htm.
Sincerely yours,
j
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): KJ10637
Device Name: OneTouch® Verio" "IQ Blood Glucose Monitoring System
Indications for Use:
The OneTouch® Verio" IQ 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 OneTouch® Verio" IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
OneTouch® Verio" IQ 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" "IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use.
The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio" IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
| 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 IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| ------------------------------------------------------------------- | -- |
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K-11063
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