INRATIO 2 PT MONITORING SYSTEM

K072727 · Hemosense, Inc. · GJS · Oct 26, 2007 · Hematology

Device Facts

• Record ID: K072727
• Device Name: INRATIO 2 PT MONITORING SYSTEM
• Applicant: Hemosense, Inc.
• Product Code: GJS · Hematology
• Decision Date: Oct 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

Device Story

System consists of monitor and disposable test strips; measures prothrombin time (PT) in capillary whole blood. Operates via modified one-stage PT test using recombinant human thromboplastin; detects clot formation through changes in electrical impedance. Used by patients on anticoagulant therapy for home monitoring. User applies capillary blood directly to test strip; monitor performs automated self-checks and provides quantitative PT results. Modifications from predicate include increased memory capacity (120 tests), updated software access interface, removed printing capability, and altered physical dimensions/display screen.

Clinical Evidence

Bench testing only. Sponsor provided risk analysis and Declaration of Conformity with Design Controls confirming product specifications were met following hardware and software modifications.

Technological Characteristics

Uses recombinant human thromboplastin reagent; sensing principle based on electrical impedance change during coagulation; monitor includes heating element for test strip temperature control; disposable test strips; hardware and software modifications from predicate.

Indications for Use

Indicated for quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood for patients on warfarin or other oral anticoagulant therapy requiring clotting time monitoring. Not for screening purposes.

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

• INRatio® System (K020679)

Submission Summary (Full Text)

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# 510(k) Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K072727

UCT 2 6 2007

| A. | Submitter: | HemoSense, Inc. |
|----|------------|------------------------|
| | | 651 River Oaks Parkway |
| | | San Jose, CA 95134 |

Contact: Doug Rundle, VP, OA/RA Phone: [phone] Fax [phone] Email: [e-mail]

Date Prepared: October 18, 2007

#### B. Device Names:

Classification name Common/usual name Proprietary name

Prothrombin Time Test Prothrombin Time Test INRatio® 2 PT Monitoring System

- ﻥ Predicate Device:
INRatio® System, K020679

### Device Description: D.

Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor. disposable test strips, instruction manual, quick reference guide, training video/DVD, and testing supplies. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The Test Strips have not been modified from the design described in K020679.

#### E. Intended Use:

The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

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#### F. Comparison with the Predicate Device:

The INRatio 2 PT Monitoring System is a hardware and software modification of the INRatio System. The INRatio 2 and the INRatio have the same intended use and use the same operating principle.

Based on the data and information presented here, the modified INRatio 2 PT Monitoring System is substantially equivalent to the INRatio System currently manufactured and distributed by HemoSense, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

OCT 26 2007

Hemosense, Inc. C/O Doug Rundle 651 River Oaks Parkway San Jose, California 95134

Re: k072727

Trade/Device Name: INRatio® 2 PT Monitoring System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: September 24, 2007 Received: September 26, 2007

Dear Mr. Rundle:

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. Ilsting 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 – Doug Rundle

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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Robert M. Booker/

Robert L. Becker, Jr., M.D., Ph.L Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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Additional Information: K072727 HemoSense INRatio 2 PT Monitoring System (Professional Use)

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ INRatio® 2 PT Monitoring System

Indications for Use:

The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oruphine Bautista

Division/Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072727

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