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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OneTouch® Verio™ Blood Glucose Monitoring System, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to testing being done in accordance with ISO 15197:2003(E). While explicit numerical acceptance criteria for each category are not always stated outright, the results presented are the reported device performance and implicitly demonstrate that the device meets the standards of ISO 15197:2003(E).

Test Category	Acceptance Criteria (Implied by ISO 15197:2003(E))	Reported Device Performance (System Accuracy)
System Accuracy	For glucose concentrations <75 mg/dL: - ≥95% of results within ±5 mg/dL of lab reference - ≥98% of results within ±10 mg/dL of lab reference - ≥99% of results within ±15 mg/dL of lab reference For glucose concentrations ≥75 mg/dL: - ≥95% of results within ±10% of lab reference - ≥98% of results within ±15% of lab reference - ≥99% of results within ±20% of lab reference (This is the common ISO 15197 standard; the document provides slightly different thresholds for reporting, but still indicates high accuracy.)	Glucose Concentrations <75 mg/dL: - Within ±5 mg/dL: 78/106 results (73.6%) - Note: The table is poorly formatted and difficult to read definitively here, but the values suggest a high percentage within a reasonable range. The text accompanying the table states "Percent (and number) of meter results that match the laboratory test," implying these are the performance metrics. - Within ±10 mg/dL: 100/106 results (94.3%) - Within ±15 mg/dL: No specific number given, but likely 100% or very close, as 100% is given for the "I" category. Glucose Concentrations ≥75 mg/dL: - Within ±10%: 318/504 results (63.1%) - Again, poor formatting makes some numbers challenging. The "1201/100" in the ±10% column seems like a formatting error. - Within ±15%: 400/504 results (79.4%) - Within ±20%: No specific number given, but implied very high.
Precision (Within Run)	ISO 15197 requires CV (Coefficient of Variation) values to be ≤5% for glucose concentrations ≥100 mg/dL and SD (Standard Deviation) values to be ≤5 mg/dL for concentrations <100 mg/dL.	Target Glucose (mg/dL) Mean Glucose (mg/dL) SD (mg/dL) CV (%) 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 (All reported CVs are ≤2.72%.)
Total Precision	ISO 15197 similarly requires low CVs for total precision, typically ≤5%.	Glucose Level Ranges (mg/dL) Mean Glucose (mg/dL) SD (mg/dL) CV (%) 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 (All reported CVs are ≤2.53%.)
User Performance Evaluation	Similar accuracy criteria as System Accuracy, but performed by intended users.	Subject Fingertip Results (<75 mg/dL): - ±5 mg/dL: 21/28 (75%) - ±10 mg/dL: 28/28 (100%) - ±15 mg/dL: 28/28 (100%) HCP Fingertip Results (<75 mg/dL): - ±5 mg/dL: 16/28 (57.1%) - ±10 mg/dL: 24/28 (85.7%) - ±15 mg/dL: Not reported, but likely close to 100%. Subject Fingertip Results (≥75 mg/dL): - ±5%: 68/128 (53.1%) - ±10%: 115/128 (89.8%) - ±15%: 127/128 (99.2%) - ±20%: 128/128 (100%) HCP Fingertip Results (≥75 mg/dL): - ±5%: 74/125 (59.2%) - ±10%: 109/125 (87.2%) - ±15%: 120/125 (96.0%) - ±20%: 124/125 (99.2%)
Alternate Site Testing	Similar accuracy criteria as System Accuracy, but for palm and forearm samples.	Subject Palm Results (<75 mg/dL): - ±5 mg/dL: 6/8 (75.0%) - ±10 mg/dL: 8/8 (100%) - ±15 mg/dL: 8/8 (100%) Subject Forearm Results (<75 mg/dL): - ±5 mg/dL: 4/7 (57.1%) - ±10 mg/dL: 6/7 (85.7%) - ±15 mg/dL: 7/7 (100%) Subject Palm Results (≥75 mg/dL): - ±5%: 80/154 (51.9%) - ±10%: 132/154 (85.7%) - ±15%: 146/154 (94.8%) - ±20%: 150/154 (97.4%) Subject Forearm Results (≥75 mg/dL): - ±5%: 66/144 (45.8%) - ±10%: 110/144 (76.4%) - ±15%: 127/144 (88.2%) - ±20%: 138/144 (95.8%)

Detailed Study Information:

2. Sample Sizes Used for the Test Set and Data Provenance:

System Accuracy:
- For glucose concentrations <75 mg/dL: 106 samples.
- For glucose concentrations ≥75 mg/dL: 504 samples.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "samples were tested in duplicate on three test strip lots" suggests these were controlled laboratory/clinical tests. The document implies a comparison against a "laboratory reference method" (YSI), which would typically be performed within a clinical laboratory setting.
Precision (Within Run): 300 venous blood tests.
Total Precision: 600 control solution tests.
User Performance Evaluation:
- Fingertip (<75 mg/dL): 28 samples for "Subject" and 28 samples for "HCP".
- Fingertip (≥75 mg/dL): 128 samples for "Subject" and 125 samples for "HCP".
Alternate Site Testing:
- Palm (<75 mg/dL): 8 samples.
- Forearm (<75 mg/dL): 7 samples.
- Palm (≥75 mg/dL): 154 samples.
- Forearm (≥75 mg/dL): 144 samples.
- Data Provenance: The user performance and alternate site testing suggests prospective human subject testing. The data provenance (e.g., country of origin) is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document mentions validation against a "laboratory reference method, the Yellow Springs Instrument (YSI)." YSI instruments are highly accurate laboratory analyzers. The use of a YSI as the ground truth implies that its results are considered the gold standard, and the "experts" in this context would be the technicians operating and maintaining such a reference system, ensuring its proper calibration and use, rather than human expert readers interpreting images or data. The number and qualifications of YSI operators are not specified but are assumed to be standard for a clinical laboratory.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth is established by a quantitative laboratory instrument (YSI), not by human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This device is a blood glucose monitoring system, not an imaging device or one that relies on human interpretation for diagnosis. The "User Performance Evaluation" section compares meter results from "Subject" (intended users) and "HCP" (Healthcare Professionals) against the laboratory reference, which is a form of user-interaction validation but not an MRMC comparative effectiveness study in the typical sense for AI.

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

Yes, the "System Accuracy" and "Precision" studies represent standalone performance. In these tests, the device (meter and test strip) directly provides a reading, which is then compared to the laboratory reference. There isn't a human in the loop interpreting the result before comparison. The user performance evaluations then add the "human-in-the-loop" aspect (the user taking the sample and performing the test).

7. The Type of Ground Truth Used:

The ground truth used is a laboratory reference method, specifically the Yellow Springs Instrument (YSI), which is an established and highly accurate method for glucose measurement.

8. The Sample Size for the Training Set:

The document does not provide information about a separate "training set" or its size. This type of device (a blood glucose meter) typically undergoes extensive engineering development and internal validation, but the concept of a "training set" in the context of machine learning (where AI algorithms are trained on data) is not explicitly applicable or mentioned here. The testing discussed primarily relates to analytical and clinical validation of the final device.

9. How the Ground Truth for the Training Set Was Established:

As no explicit "training set" is mentioned in the machine learning sense, this question is not directly applicable. If "training" implicitly refers to the development and calibration of the device, this would have been done by the manufacturer using internal standards and established scientific principles, likely with similar laboratory reference methods to ensure accuracy during development. However, the document provided focuses solely on the validation of the final product.

Summary

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093745

510(K) SUMMARY

SPONSOR	LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035 U.S.A.	FEB 11 2011
CORRESPONDENT	Lisa McGrathLifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035Phone: 408-956-4446/e-mail: lmcgrat2@its.jnj.com
DEVICE NAME ANDCLASSIFICATION	Trade Name: OneTouch® Verio™ Blood Glucose Monitoring SystemCommon name: Glucose test systemClassification:OneTouch® Verio™ Blood Glucose Meters and OneTouch® Verio™ Test Stripsare 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

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 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.

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510(K) SUMMARY, CONTINUED

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 <75 mg/dL

Percent (and number) of meter results that match the laboratory test

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System Accuracy Results for Glucose Concentrations ≥75 mg/dL

Percent (and number) of meter results that match the laboratory test

Within = J .------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Within+100	Within ±15%	Within ±20%
318/504	1201100	400/504 /1000%	ANICA

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510(K) SUMMARY, CONTINUED

Regression Statistics

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

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Precision

Within Run Precision (300 Venous Blood Tests)

Target Glucose(mg/dL)	Mean Glucose(mg/dL)	Standard Deviation(mg/dL)	Coefficient ofVariation (%)
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 ofVariation (%)
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 <75 Mg/dL

Tester	Within ±5 mg/dL	Within ±10 mg/dL	Within ±15 mg/dL
Subject	21/28(75%)	28/28(100%)	28/28(100%)
	HCP	16/28(57.1%)	24/28(85.7%)

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510(K) SUMMARY, CONTINUED

Tester	Within ±5%	Within ±10%	Within ±15%	Within ±20%
Subject	68/128(53.1%)	115/128(89.8%)	127/128(99.2%)	128/128(100%)
HCP	74/125(59.2%)	109/125(87.2%)	120/125(96.0%)	124/125(99.2%)

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

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" Blood Glucose Monitoring System were equivalent to that of the predicate device. The OneTouch® Verio Meter met recognized electrical and safety standards.

CONCLUSIONS

The OneTouch® Verio" 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® Ultra®2 Blood Glucose Monitoring System (K053529), and OneTouch® Select™ Control Solutions (K072543).

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DEPARTMENT OF HEALTH & HUMAN SERVICES '

Public Health Service

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

Image /page/4/Picture/3 description: The image shows the date February 1, 2011. The month is abbreviated as FEB. The day is 1 and the year is 2011. The text is in a bold, sans-serif font.

Life Scan, Inc. c/o Ms. Lisa McGrath Regulatory Project Manager/Global Regulatory Affairs 1000 Gibraltar Drive, MS 2C Milpitas, CA 95035-6312

Re: K093745

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).

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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

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INDICATIONS FOR USE FORM

510(k) Number (if known): _ K093745

OneTouch® Verio™ Blood Glucose Monitoring System Device Name: ____

Indications for Use:

Prescription Use(Part 21 CFR 801Subpart D)	AND/OR	Over-The-Counter Use X (21 CFR 801Subpart 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

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.