HARMONY INR MONITORING SYSTEM

K022922 · Lifescan, Inc. · GJS · Sep 30, 2002 · Hematology

Device Facts

• Record ID: K022922
• Device Name: HARMONY INR MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: GJS · Hematology
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

For the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.

Device Story

Harmony INR Monitoring System consists of a meter and disposable test strips. Device measures prothrombin time (PT) in whole blood samples. User applies blood drop to test strip; blood enters reaction cells containing thromboplastin reagents to initiate clotting. Meter uses optical sensing, passing light beam through sample to monitor clotting process. Device detects clot formation and calculates/displays result in International Normalized Ratio (INR) units. Used in home environment by patients/caregivers or in clinical settings by healthcare professionals. Enhancements over predicate include reduced calibration code requirements and active LCD display integrity check. Output assists clinicians in managing oral anti-coagulation therapy, enabling patient self-monitoring and improved therapeutic control.

Clinical Evidence

Performance testing compared the Harmony System to the predicate Rubicon device and a reference laboratory system. Study evaluated accuracy and precision of PT/INR measurements. Results demonstrated equivalent performance in meeting user requirements and clinical accuracy standards.

Technological Characteristics

System comprises a meter and disposable test strips. Sensing principle: optical (light beam transmission through blood sample). Reagent: thromboplastin. Output: INR units. Environmental/non-clinical testing performed per IEC 60601. Features active LCD display integrity check and reduced calibration code requirements.

Indications for Use

Indicated for quantitative determination of prothrombin time (PT) in capillary whole blood (patients/caregivers) or capillary/venous whole blood (healthcare professionals) to monitor oral anti-coagulation therapy.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• Rubicon™ Prothrombin Time Monitoring System (K001699)

Submission Summary (Full Text)

{0}------------------------------------------------

Convenience. Confidence. Control.

Johnson+Johnson company

SEP 3 0 2002

# 510(k) Summary

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Tel [phone] Fax [phone] www.LifeScan.com

| Submitted By: | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035<br>[phone]<br>[phone] (fax) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | John E. Hughes |
| Date of Preparation: | September 3, 2002 |
| Establishment Registration<br>No: | 2939301 |
| Device Name: | Harmony™ INR Monitoring System |
| Common/Classification<br>Name: | Prothrombin Time Test |
| Device Classification: | Class II |
| Regulation Number: | CFR 864.7750 |
| Classification Panel: | Hematology |
| Product Code: | GJS |
| Predicate Device: | Rubicon™ Prothrombin Time Monitoring System<br>K001699 |

# Device Description:

The Harmony System consists of a meter and test strip. When a drop of blood is placed on the test strip, the blood is drawn into the reaction cells and mixed with reagents that cause blood clotting to begin. The meter monitors the blood clotting process by passing a light beam through the blood sample being tested. The meter detects blood clot formation and, at the conclusion of the test, the prothrombin time is displayed in International Normalized Ratio (INR) units.

#### Intended Use:

For the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.

LifeScan, Inc. Harmony ™ INR Monitoring System 510(k) Summary

{1}------------------------------------------------

# Comparison to Predicate Device:

The Harmony INR Monitoring System and the Rubicon Prothrombin Time Monitoring System both consist of a meter and disposable test strip. Both systems employ whole blood as a test sample and can be used by laypersons in the home environment to monitor oral anti-coagulation therapy. Both employ thromboplastin to cause blood coagulation.

The systems differ in that the Harmony System has been enhanced by reducing the number of calibration codes required which makes the product simpler to use. In addition, an active use confirmation was added to ensure the integrity of the LCD display prior to each use.

## Environmental and Non-Clinical Testing:

Applicable environmental and non-clinical testing was performed per IEC 60601 and other applicable standards and procedures. The Harmony INR Monitoring System passed all tests.

## Performance Testing:

The study conducted to compare equivalency of the Rubicon 510(k) cleared device to the modified Harmony System met the performance requirements for accuracy and precision relative to the reference laboratory system. Equivalent performance in meeting user requirements was determined.

#### Conclusion:

The test results demonstrate the Harmony INR Monitoring System is substantially equivalent to the Rubicon Prothrombin Time Monitoring System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

SEP 3 0 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John E. Hughes Senior Manager, Regulatory Submissions LifeScan. Inc. 1000 Gibraltar Drive Milpitas, California 95035

Re: k022922

> Trade/Device Name: Harmony™ INR Monitoring System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: September 3, 2002 Received: September 4, 2002

Dear Mr. Hughes:

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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2

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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

{4}------------------------------------------------

510(k) Number:

K022923

Name:

Harmony™ INR Monitoring System

#### Indications for Use:

The Harmony INR Monitoring System is indicated for the quantitative determination of prothrombin time (PT) in capillary whole blood by properly selected and trained patients or their caregivers, or in capillary or venous whole blood by health care professionals, as an aid in monitoring oral anti-coagulation therapy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

Josephine Bautcher

(Division Sign-Off) (Division of Clinical Laboratory Devices 222922