The OneTouch Ultra Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Ultra Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Device Description

The OneTouch Ultra Blood Glucose Monitoring System consists of the OneTouch Ultra Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler with OneTouch ClearCap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® meter hardware and software has been modified. There are no changes to other system testing components compared to the currently marketed product.

AI/ML Overview

This document describes the OneTouch® Ultra® Blood Glucose Monitoring System, which measures glucose in fresh capillary whole blood. The system is intended for use by people with diabetes at home and/or by healthcare professionals in a clinical setting to monitor diabetes control. It is specifically indicated for use on the finger, forearm, or palm.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for glucose measurement accuracy. Instead, it refers to compliance with the ISO 15197:2003(E) standard. For blood glucose monitoring systems, ISO 15197:2003(E) typically sets accuracy criteria, often related to the percentage of results falling within specific ranges compared to a reference method (e.g., within ±15% or ±20%).

Since specific numerical criteria are not provided, we can only state the overall performance claim made in the document.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 15197:2003(E) for system accuracy and electrical safety.	A system accuracy study demonstrated that the modified OneTouch Ultra Blood Glucose Monitoring System and the currently marketed OneTouch Ultra Blood Glucose Monitoring System are substantially equivalent, and the modified meter was tested in accordance with ISO 15197:2003(E) including system accuracy.
Performance, safety, and effectiveness equivalent to the predicate device.	Design Verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the modified OneTouch Ultra Blood Glucose Monitoring System were equivalent with that of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on:

The sample size used for the test set in the system accuracy study.
The country of origin for the data.
Whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on:

The number of experts used to establish ground truth.
The qualifications of those experts.

Given that this is a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by an expert consensus on interpreting images or clinical data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This is understandable as the "ground truth" in this context would likely be a precise numerical measurement from a laboratory reference instrument, not a subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is a blood glucose monitor, not an imaging device.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance assessment (algorithm only without human-in-the-loop performance) was done. The "system accuracy study" and "Design Verification (including software verification and validation testing)" are examples of standalone performance evaluations for a medical device. The device's performance is measured directly against a reference.

7. The Type of Ground Truth Used

The document implies that the ground truth used for the system accuracy study would be a laboratory reference method for glucose measurement. While not explicitly stated, this is standard practice for blood glucose meters to ensure accuracy. The ISO 15197:2003(E) standard inherently requires comparison to a highly accurate reference method.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. For in vitro diagnostic devices like blood glucose meters, the development often involves analytical studies, calibration, and verification rather than "training sets" in the machine learning sense, although internal data is used during development.

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

The document does not provide information on how ground truth for a training set was established. As mentioned above, the concept of a "training set" with established ground truth, as used in machine learning, is not explicitly discussed for this type of device. The development process would rely on precise chemical and analytical methods to calibrate and verify the device's measurement capabilities.

Summary

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K062195

OneTouch® Ultra® Blood Glucose Monitoring System

510(k) Summary

AUG 16 2006

Submitter	LifeScan, Inc.1000 Gibraltar Drive
	Milpitas, CA 95035-6312
	510(k) Contact: Cindy Morrow, LifeScan, Inc.
	Alternate 510(k) Contact: Mary Ellen Holden, LifeScan, Inc.
Device Name	OneTouch® Ultra® Blood Glucose Monitoring System
	Common name: Glucose test system
	Classification:
	(1) OneTouch® Ultra® Blood Glucose Meters and
	OneTouch® Ultra® Test Strips are Class II devices
	(21 CFR § 862.1345)
	(2) OneTouch® Ultra® Control Solution is a Class I
	device (21 CFR § 862.1660)
	(3) OneTouch® UltraSoft® Adjustable Blood Sampler
	with OneTouch® ClearCap™ and OneTouch®
	UltraSoft® Sterile Lancets are Class I (exempt) devices
	(21 CFR § 878.4800)

System Description

OneTouch Ultra Blood Glucose Monitoring System Predicate Device

Intended Use

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510(K) Summary, Page 2 of 2

Comparison to Predicate Device

The modifications to the device encompass meter hardware and software/firmware changes. The labeling has been updated to provide electrical safety testing certification in accordance with ISO 15197:2003(E). There has been no change to the intended use, operating principle, functionality, or material composition of the device.

Technological Characteristics

There has been no change to the fundamental scientific technology.

Summary of Performance Characteristics

There has been no change to the performance characteristics of the system.

A system accuracy study demonstrated that the modified OneTouch Ultra Blood Glucose Monitoring System and the currently marketed OneTouch Ultra Blood Glucose Monitoring System are substantially equivalent.

Design Verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the modified OneTouch Ultra Blood Glucose Monitoring System were equivalent with that of the predicate device.

The modified meter was tested in accordance with ISO 15197:2003(E) including system accuracy and electrical safety testing. In addition, testing was performed to verify the effectiveness of the changes to the meter hardware and software.

Conclusion

The modified OneTouch Ultra Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 1 6 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cindy Morrow Sr. Regulatory Submission Specialist LifeScan. Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Re: K062195

Trade/Device Name: OneTouch® Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 31, 2006 Received: August 1, 2006

Dear Ms. Morrow:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo ichet notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, 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

510(k) Number (if known): K06 x \ (5

Device Name: OneTouch® Ultra® Blood Glucose Monitoring System

Indications For Use:

The OneTouch Ultra Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare dragmootic as an aid to monitor the effectiveness of diabetes control.

The OneTouch Ultra Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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.