The ONETOUCH® Profile Meter is used for the quantitative measurement of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.

Device Description

The labeling of this device was modified to enhance instructions for use advising users to insure the display is operating properly each time they perform a test.

AI/ML Overview

The provided document is a 510(k) summary for the ONETOUCH® Profile Meter, specifically regarding a change in labeling. It confirms the device's substantial equivalence to previously marketed devices but does not contain information regarding new acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

Identifying the device and applicant.
Stating its intended use.
Describing a minor labeling change ("The labeling of this device was modified to enhance instructions for use advising users to insure the display is operating properly each time they perform a test.").
Confirming substantial equivalence based on this labeling change.

Therefore, I cannot provide the requested information as it is not present in the given text.

Summary of missing information:

A table of acceptance criteria and the reported device performance: Not available. The document discusses a labeling change, not performance criteria.
Sample size used for the test set and the data provenance: Not available. No new testing is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
Adjudication method for the test set: Not available.
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, as this is a glucose meter, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not available.
The sample size for the training set: Not applicable, as this is a glucose meter, not a device that typically involves a "training set" in the context of AI/machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

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'JUN 2 8 2002

K021943

510(k) SUMMARY

(As required by 21 C.F.R. § 807.92)

Submitted By:	Lifescan, Inc.1000 Gibraltar DriveMilpitas, CA 95035
Contact Person:	John E. HughesPhone: 408-942-5903Fax: 408-942-5906
Date SummaryPrepared:	June 20, 2002
Device Name	ONETOUCH® Profile Meter
Classification	862.1345 Glucose Test System
Description of theChanged Labeling	The labeling of this device was modified to enhance instructions foruse advising users to insure the display is operating properly eachtime they perform a test.
Statement ofIntended Use:	The ONETOUCH Profile Meter is used for the quantitativedetermination of glucose in whole blood by lay persons in the homeand by medical professionals in clinical settings as an aid inmonitoring effectiveness of diabetes management.
SubstantialEquivalence:	The current labeling for this meter advises users to check that thedisplay is operating properly. The revised labeling clarifies that theuser should check the display integrity each time a test isperformed.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 8 2002

Mr. John E. Hughes Manager Regulatory Submissions LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

K021943 Re:

Trade/Device Name: OneTouch® Profile Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Hughes:

We have reviewed vour 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

K021943

ONETOUCH® Profile Meter Device Name:

Indications for Use:

Hap Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021943

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

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.