The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

Device Description

The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the OneTouch® UltraLink™ Blood Glucose Monitoring System, based on the provided text:

Acceptance Criteria and Device Performance

Performance Characteristic	Acceptance Criteria (Test Method)	Reported Device Performance
Accuracy	ISO 15197:2003, Section 7.3 (7.4)	95% of individual glucose results fell within ± 15 mg/dL of the reference method for glucose concentrations < 75 mg/dL AND within ± 20% for glucose concentrations ≥ 75 mg/dL.
Precision	ISO 15197:2003, Section 7.2	Demonstrated acceptable system precision.
User Performance	ISO 15197:2003, Section 8	Demonstrated equivalent ability of lay and professional users to obtain suitable results.
Linearity	CLSI/NCCLS EP-6A	Demonstrated acceptable system linearity over the measurement range.
Safety and Reliability	ISO 15197:2003, Section 6	Demonstrated acceptable safety and reliability.

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests. However, the User Performance study mentions "two U.S. clinical sites," implying a test set collected from human subjects.
- Data Provenance:
  - Country of Origin: U.S. (for User Performance studies).
  - Retrospective or Prospective: Not explicitly stated, though a "user performance" study generally implies prospective data collection, especially in "clinical sites."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document refers to a "reference method" for accuracy. For blood glucose monitoring systems, the ground truth is typically established using a high-precision laboratory analyzer, not "experts" in the human sense. The document does not specify the number or qualifications of individuals operating this reference method.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not described. Blood glucose monitoring systems typically compare device readings directly against a highly accurate laboratory reference method, which serves as the "ground truth." There is no mention of physician or expert adjudication for this type of device performance evaluation.
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
- No. This is not applicable to a blood glucose monitoring system. This type of study refers to diagnostic imaging or interpretation tasks, where human readers (e.g., radiologists) interpret cases with or without AI assistance. The OneTouch® UltraLink™ is a direct measurement device; its performance is evaluated against a reference method and user ability to operate it, not against human interpretation of complex data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance characteristics like Accuracy, Precision, and Linearity are assessed for the "system" (meter and test strips) as a standalone device against a reference method. The "User Performance" study specifically evaluates human interaction with the device, so it includes human-in-the-loop, but the other tests are essentially standalone performance of the measurement technology.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Reference method: For accuracy, the ground truth was established by a "reference method" (presumably a laboratory analyzer, typically traceable to an international standard like NIST, for precise glucose measurement).
- No expert consensus, pathology, or outcomes data ground truth was used for the technical performance characteristics.
The sample size for the training set
- Not applicable/Not mentioned. The OneTouch® UltraLink™ Blood Glucose Monitoring System is not an AI/machine learning device that requires a "training set" in the conventional sense. Its underlying technology (enzymatic electrochemical measurement) is well-established, and the system is calibrated during manufacturing.
How the ground truth for the training set was established
- Not applicable. As noted above, there is no "training set" for this type of device.

Summary

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K073231

APR 1 8 2008

510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92

Submitted by:	LifeScan, Inc.1000 Gibralter Ave.Milpitas, CA. 95035
Contact:	Kim FondaSenior Regulatory Affairs SpecialistPhone: (408) 942-3733FAX: (408) 942-5906E-Mail: kfonda@lfsus.jnj.com
Summary Date:	November 14, 2007
Trade Name:	OneTouch ® UltraLink ™ Blood Glucose Monitoring System
Common Name:	Blood Glucose Monitor
	Device Classification: Class II, Glucose Test System (21 CFR §862.1345, Product Code NBW)

Substantial Equivalence

The OneTouch® UltraLink™Blood Glucose Monitoring System is substantially equivalent to the OneTouch® Ultra®2 Blood Glucose Monitoring System as cleared under K053529. Both devices have a similar intended use, measure the same sample type and have similar performance characteristics. The OneTouch® UltraLink™ Blood Glucose Monitoring System is substantially equivalent to the BD Paradigm Link® Blood Glucose Monitor as cleared under K040603 for the ability to transmit blood glucose results using Radio-Frequency telemetry.

Device Description

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UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

Intended Use

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

Predicate Device	Similarities to Subject Device	Differences between SubjectDevice(Modifications)
OneTouch® Ultra®2 BloodGlucose Monitoring System(K053529)Quantitative measurementof blood glucose	Same intended useSame sample typeSame fundamental scientifictechnologySame system components	Meter: ergonomic/physicaldesign, electronic/hardware,software/firmware.Instructions for use - addition ofRadio Frequency use information
BD Paradigm Link® BloodGlucose Monitor(K040603)Radio-Frequencytransmission of bloodglucose results.	Same fundamental scientifictechnologyEquivalent radio-Frequencyprotocol specifications	RF module contained in adifferent blood glucose meter

Technological Characteristics

Comparison with Predicate devices

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Performance Summary

PerformanceCharacteristic	Test method employed	Results
Precision	ISO 15197:2003,Section 7.2	The OneTouch® UltraLink™ Blood GlucoseMonitoring System demonstrated acceptablesystem precision.
Accuracy	ISO 15197:2003Section 7.3 (7.4)	Ninety-five percent (95 %) of the individualglucose results fell within ± 15 mg/dL of theresults of the reference method at glucoseconcentrations < 75 mg/dL and within± 20 % at glucose concentrations ≥75 mg/dL.
User Performance	ISO 15197:2003, Section 8	Results from performance and human factorsstudies at two U.S. clinical sites demonstratedequivalent ability of lay and professional users toobtain results suitable for the intended use of thedevice.
Linearity	CLSI/NCCLS EP-6A	The OneTouch® UltraLink™ Blood GlucoseMonitoring System demonstrated acceptablesystem linearity over the measurement range.
Safety andReliability	ISO 15197:2003, Section 6	The OneTouch® UltraLink™ Blood GlucoseMonitoring System demonstrated acceptablesafety and reliability per the test methodsdescribed.

Conclusion from Performance Evaluation

The OneTouch® UltraLink™ Blood Glucose Monitoring System demonstrates substantial equivalence to the OneTouch® Ultra®2 Blood Glucose Monitoring System, and to the BD Paradigm Link™ Blood Glucose Meter for the Radio-Frequency (wireless) communication feature.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 8 2008

LifeScan, Inc. c/o Ms. Kim Fonda Regulatory Project Leader 1000 Gibraltar. Drive Milpitas, CA 95035

Re: K073231

Trade/Device Name: One Touch Ultralink Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 01, 2008 Received: April 02, 2008

Dear Ms. Fonda:

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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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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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Indication for Use

510(k) Number (if known): K073231

Device Name: OneTouch® UltraLink™ Blood Glucose Monitoring System

Indications For Use:

The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson
Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073231

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.