AVOCET PT

K980839 · Avocet Medical, Inc. · JPA · Sep 30, 1998 · Hematology

Device Facts

• Record ID: K980839
• Device Name: AVOCET PT
• Applicant: Avocet Medical, Inc.
• Product Code: JPA · Hematology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Avocetor is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

Device Story

The AvocetpT is a membrane-based, dry-reagent point-of-care system for professional use. It accepts fresh capillary or venous whole blood and citrated venous plasma. A membrane separates plasma from red cells; the membrane contains calcium and thromboplastin to initiate the extrinsic coagulation pathway. Thrombin generation is monitored optically via a rhodamine-110-based fluorescent thrombin substrate (Tos-Gly-Pro-Arg)2-Rhodamine 110. The system analyzes fluorescence kinetics to calculate a prothrombin-time-equivalent parameter, which is converted to an International Normalized Ratio (INR). Healthcare providers use the INR output to monitor and manage patient anticoagulation therapy.

Clinical Evidence

Field studies compared the AvocetpT to the CoaguChek and a reference method, demonstrating equivalent performance with a correlation coefficient (r) > 0.95. Precision and linearity evaluations were performed and found acceptable. Additional bench testing addressed interfering substances, hematocrit, RBC abnormalities, and factor deficiencies.

Technological Characteristics

Membrane-based, dry-reagent system. Uses optical fluorescence detection of thrombin generation via (Tos-Gly-Pro-Arg)2-Rhodamine 110 substrate. Measures extrinsic coagulation pathway. Point-of-care form factor.

Indications for Use

Indicated for health care professionals to monitor prothrombin time (INR) in patients undergoing warfarin-type (coumarin) anticoagulation therapy using fresh capillary whole blood, citrated venous whole blood, or citrated venous plasma.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Boehringer Mannheim Coaguchek System

Submission Summary (Full Text)

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SEP 3 0 1998

Image /page/0/Picture/2 description: The image shows the logo for AOCET Medical Incorporated. The logo features a stylized "A" connected to the letters "OCET" in a sans-serif font. Below the letters is the text "MEDICAL INCORPORATED" in a smaller font size. The logo is black and white.

1696 Dell Ave., Campbell, CA 95008 · 408/374-7262 · Fax [phone]

Avocet Medical, Inc. Avocetpr System 510(k) Premarket Notification

## 510(k) Summary

Introduction:

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

- 1. Submitter's name Avocet Medical, Inc. address, contact 1696 Dell Avenue Campbell, CA 95008 [phone] (phone) [phone] (fax)
Contact person: Judith Blunt

Date prepared: June 8, 1998

- Common or Usual Name: Prothrombin Time Test (INR) 2. Device name
Classification Name: Prothrombin Time Test

Trade or Proprietary Name: AvocetpT

- 3. Predicate device The Boehringer Mannheim Coaguchek™ System: device for testing Prothrombin Time and INR in whole blood.
The Avocetpr is a membrane-based, dry-reagent system for 4. Device description use with fresh capillary or venous whole blood, and citrated venous whole blood or citrated plasma. The system uses an membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a

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AOCET
MEDICAL INCORPORATED

1696 Dell Ave., Campbell, CA 95008 · 408/374-7262 · Fax [phone]

Avocet Medical, Inc. Avocetpr System 510(k) Premarket Notification

> prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value.

5. Intended use: The Avocetor is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

6. Comparison to The Avocetor is substantially equivalent in materials, design and intended use to other products that measure predicate device Prothrombin Time INR in human blood. Most notably, it is substantially equivalent to the CoaguChek™, manufactured by the Boehringer Mannheim Corporation. Both products are prothrombin time devices, have the same intended use and serve the same professional, point-of-care market. The AvocetpT and the CoaguChek both measure the extrinsic coagulation pathway, expressed as an International Normalized Ratio. Both products measure the elapsed time between the start of the reaction and the formation of thrombin using a dry reagent thromboplastin. While CoaguChek measures this formation as expressed through the conversion of fibrinogen (a thrombin substrate) to fibrin via the motion of magnetic particles, the AvocetpT measures this formation as expressed through the conversion of (Tos-Gly-Pro-Arg)2-Rhodamine 110 (a thrombin substrate) to free Rhodamine via a change in fluorescence.

7. Summary of The accuracy of the Avocetor was compared to the performance data CoaguChek and a reference method in field studies and found to be equivalent (r>0.95). Precision and linearity evaluations were done on the Avocetor and found to be acceptable. Additional testing of interfering substances, hematocrit, RBC abnormalities and factor deficiencies were performed and the results are reflected in the product labeling.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, rendered in black and white.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP 3 0 1998

Ms. Judith Blunt Director of Regulatory Affairs and Quality Assurance Avocet Medical Incorporated 1696 Dell Avenue Campbell, California 95008

Re : K980839/S1 Trade Name: Avocetpr Regulatory Class: II Product Code: JPA Dated: July 2, 1998 Received: July 6, 1998

Dear Ms. Blunt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 leqally 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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March 12, 1998

# PREMARKET NOTIFICATION INDICATIONS FOR USE FORM

Page 1 of 1

510(K) Number: Not known

Device Name: AvocetpT System

The Avocetor is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). It uses fresh capillary whole blood, citrated venous whole blood or citrated venous plasma samples. It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.

This does not differ substantially from the intended use of the Boehringer Mannheim Coagu Chek (predicate device).

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

Concurrence of CDRH, Office of Device Evaluation/(ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | k980839 |

| Prescription Use | <div> <div style="display:inline-block;">✓</div> OR Over-The-Counter Use ____ </div> |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96 |