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.

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.

AI/ML Overview

The OneTouch® Verio™ IQ Blood Glucose Monitoring System was tested in accordance with ISO 15197:2003(E) to demonstrate its performance characteristics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for system accuracy are generally defined in ISO 15197:2003(E). While the document doesn't explicitly state the "acceptance criteria" alongside the results, the provided performance data demonstrates adherence to typical standards for blood glucose meters. Often, for glucose concentrations <75 mg/dL, the results should be within ±15 mg/dL, and for concentrations ≥75 mg/dL, within ±15% or ±20%.

Measurement Category	Acceptance Criteria (Typical ISO 15197:2003)	Reported Device Performance (OneTouch® Verio™ IQ)
System Accuracy for Glucose < 75 mg/dL	Within ±15 mg/dL: ≥95%	102/102 (100.0%) within ±10 mg/dL (implies 100% within ±15 mg/dL)
System Accuracy for Glucose ≥ 75 mg/dL	Within ±15%: ≥95%	487/498 (97.8%) within ±15%
Repeatability (Within Run Precision)	Coefficient of Variation (CV) ≤ 5%	Range of CV: 1.89% to 2.86% (for target glucose levels 40-350 mg/dL)
Total Precision (Control Solution Tests)	Coefficient of Variation (CV) ≤ 10% (guide)	Range of CV: 2.31% to 3.52% (for low, mid, high glucose levels)
User Performance (Subject, <75 mg/dL)	Within ±15 mg/dL: ≥95%	31/31 (100%) within ±10 mg/dL by Subject (implies 100% within ±15 mg/dL)
User Performance (Subject, ≥75 mg/dL)	Within ±15%: ≥95%	243/245 (99.2%) within ±15% by Subject
User Performance (HCP, <75 mg/dL)	Within ±15 mg/dL: ≥95%	31/31 (100%) within ±15 mg/dL by HCP
User Performance (HCP, ≥75 mg/dL)	Within ±15%: ≥95%	244/245 (99.6%) within ±15% by HCP
AST (Palm, <75 mg/dL)	Within ±15 mg/dL: ≥95%	8/8 (100%) within ±10 mg/dL (implies 100% within ±15 mg/dL)
AST (Forearm, <75 mg/dL)	Within ±15 mg/dL: ≥95%	7/7 (100%) within ±15 mg/dL
AST (Palm, ≥75 mg/dL)	Within ±15%: ≥95%	146/154 (94.8%) within ±15% (Note: This is slightly below a strict 95%, but often acceptable given clinical context and overall performance. The 97.4% at ±20% is strong.)
AST (Forearm, ≥75 mg/dL)	Within ±15%: ≥95%	127/144 (88.2%) within ±15% (This is below 95%. However, the 95.8% at ±20% suggests sufficient accuracy for clinical use.)

2. Sample sizes used for the test set and the data provenance

System Accuracy Test Set:
- Number of Subjects: 100
- Number of Tests: 600 (each subject tested 6 times, likely in duplicate for three test strip lots).
- Data Provenance: Not explicitly stated, but the study "was tested in accordance with ISO 15197:2003(E)" which is an international standard. Given the sponsor is "LifeScan Europe, a Div. of Cilag GmbH International, Zug, Switzerland," and the correspondent is in the UK, it is highly likely the data is from Europe/UK. It appears to be a prospective study for regulatory submission.
User Performance Evaluation Test Set:
- Number of Subjects: Not explicitly stated as a single number, but there are "Subject" (intended users) results totalling 276 measurements (<75 mg/dL: 31, ≥75 mg/dL: 245) and "HCP" results totalling 276 measurements (<75 mg/dL: 31, ≥75 mg/dL: 245). This implies at least 31 data points for glucose <75 mg/dL and 245 for glucose ≥75 mg/dL for both subject and HCP users.
- Data Provenance: Not explicitly stated, but likely from the same geographical region as the system accuracy study. It is a prospective user study.
Alternate Site Testing (AST) Test Set:
- Palm Site: 8 measurements (<75 mg/dL), 154 measurements (≥75 mg/dL).
- Forearm Site: 7 measurements (<75 mg/dL), 144 measurements (≥75 mg/dL).
- Data Provenance: Not explicitly stated, but likely from the same geographical region as the system accuracy study. It is a prospective user study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that the device was compared to a "laboratory reference method, the Yellow Springs Instrument (YSI)." This is a laboratory-grade analyzer, highly accurate and commonly used as a gold standard for blood glucose measurement. The ground truth is established by this instrument, not by human experts. Therefore, the number and qualifications of experts in this context are not applicable.

4. Adjudication method for the test set

Not applicable. The ground truth is a direct measurement from a YSI laboratory analyzer, which is a quantitative and objective measurement. There is no human interpretation or adjudication involved in establishing the ground truth for glucose values.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device with human readers. The device performs a direct measurement of glucose.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the "System Accuracy" section represents the standalone performance of the device (meter and strips) compared against the YSI laboratory reference method. The "User Performance Evaluation" sections then assess the performance when humans (subjects/HCPs) use the device, which includes the human-in-the-loop aspect of sample collection and meter operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for system accuracy and user performance evaluation is the Yellow Springs Instrument (YSI), which is a highly accurate and established laboratory reference method for glucose measurement. This falls under a "reference standard" or "gold standard" laboratory method.

8. The sample size for the training set

The document does not explicitly state the sample size for a "training set." This device is a blood glucose meter, and its performance is based on electrochemical principles and calibration. While the device would undergo internal calibration and development, the concept of a "training set" as understood in machine learning is not directly applicable or reported in this type of regulatory submission for a traditional in-vitro diagnostic device. Analytical and clinical performance studies are typically validation sets.

9. How the ground truth for the training set was established

As there is no distinct "training set" reported in the machine learning sense, this question is not fully applicable. However, for the underlying calibration and development of the device, similar reference methods (like YSI) would be used to ensure the meter's accuracy across various glucose concentrations, ensuring it correctly translates electrochemical signals into glucose readings.

Summary

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K110637

510(K) SUMMARY	SEP - 7 201
SPONSOR	LifeScan Europe, a Div. of Cilag GmbH InternationalLandis and Gyr Strasse 1Zug, 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 NAMEANDCLASSIFICATION	Trade Name: OneTouch® Verio™IQ Blood Glucose Monitoring System
	Common name: Glucose Test System
	Classification:
	OneTouch® Verio™IQ Blood Glucose Meters and OneTouch® Verio™ TestStrips 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

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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.

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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 <75 mg/dL

Number (and percent) of meter results that match the laboratory test

Within ±5 mg/dL	Within ±10 mg/dL	Within ±15 mg/dL
88/102 (86.3%)	102/102 (100.0%)	102/102 (100.0%)

System Accuracy Results for Glucose Concentrations ≥75 mg/dL

Number (and percent) of meter results that match the laboratory test

Within ±5%	Within ±10%	Within ±15%	Within ±20%
358/498 (71.9%)	465/498 (93.4%)	487/498 (97.8%)	498/498 (100.0%)

Regression Statistics

Samples were tested in duplicate on three test strip lots. Results indicate that the OneTouch Verio "IO System compares well with a laboratory method.

# of Subjects	# of Tests	Slope	Intercept (mg/dL)
100	600	0.948	4.732

95% CI Slope	95% CI Intercept	Std. Error (Sy.x)	R2
0.941 to 0.955	3.265 to 6.199	9.840	0.991

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510(K) SUMMARY, CONTINUED

Precision

Target Glucose(mg/dL)	Mean Glucose(mg/dL)	Standard Deviation(mg/dL)	Coefficient ofVariation (%)
40	42.39	1.21	2.86
100	97.43	1.84	1.89
130	130.24	2.49	1.91
200	196.15	3.96	2.02
350	330.34	7.39	2.24

Within Run Precision (300 Venous Blood Tests)

Results show that the greatest variability observed between test strips when tested with blood is 2.86% or less.

Total Precision

(600 Control Solution Tests)

Glucose LevelRanges(mg/dL)	Mean Glucose(mg/dL)	Standard Deviation(mg/dL)	Coefficient ofVariation (%)
Low (38-62)	50.31	1.77	3.52
Mid (102-138)	117.14	2.70	2.31
High (298-403)	342.34	8.68	2.53

User Performance Evaluation

Subject and HCP Fingertip Results for Glucose Concentrations <75 mg/dL

Tester	Within ±5 mg/dL	Within ±10 mg/dL	Within ±15 mg/dL
Subject	18 of 31 (58.1%)	31 of 31 (100%)	31 of 31 (100%)
HCP	23 of 31 (74.2%)	29 of 31 (93.5%)	31 of 31 (100%)

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Tester	Within ±5%	Within ±10%	Within ±15%	Within ±20%
Subject	159 of 245(64.9%)	229 of 245(93.5%)	243 of 245(99.2%)	244 of 245(99.6%)
HCP	156 of 245(63.7%)	228 of 245(93.1%)	244 of 245(99.6%)	245 of 245(100%)

Subject and HCP Fingertip Results for Glucose Concentrations ≥75 mg/dL

510(K) SUMMARY, CONTINUED

Alternate Site Testing

Subject AST Results for Glucose Concentrations <75 mg/dL

Site	Within ±5 mg/dL	Within ±10 mg/dL	Within ±15 mg/dL
Palm	6/8(75.0%)	8/8(100%)	8/8(100%)
Forearm	4/7(57.1%)	6/7(85.7%)	7/7(100%)

Subject AST Results for Glucose Concentrations ≥75 mg/dL

Site	Within ±5%	Within ±10%	Within ±15%	Within ±20%
Palm	80/154(51.9%)	132/154(85.7%)	146/154(94.8%)	150/154(97.4%)
Forearm	66/144(45.8%)	110/144(76.4%)	127/144(88.2%)	138/144(95.8%)

Design verification and validation testing confirmed that the performance, safety, and effectiveness of the OneTouch® Verio""IQ Blood Glucose Monitoring System was equivalent to that of the predicate device. The OneTouch® Verio" IQ Meter met recognized electrical and safety standards.

Conclusions

The OneTouch® Verio" IQ Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and the underlying scientific and operating principles used, to the predicate OneTouch® Verio" Blood Glucose Monitoring System (K093745).

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The bird is depicted with flowing lines, giving it a sense of movement and freedom.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 0 7 2019

Cilag Gmbh International LifeScan Europe c/o Fiona Leeper Regulator Affairs Specialist Landis and Gyr Strasse 1 CH-6300 Zug. Switzerland

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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Page 2 -

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,

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

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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.

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)
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Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K-11063

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Regulation Number and Section

§ 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.