AVOCET ACUSURE SYSTEM

K991286 · Avocet Medical, Inc. · GJS · Nov 18, 1999 · Hematology

Device Facts

• Record ID: K991286
• Device Name: AVOCET ACUSURE SYSTEM
• Applicant: Avocet Medical, Inc.
• Product Code: GJS · Hematology
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). The AvocetpT-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

Device Story

System monitors prothrombin time (PT) and INR in fresh capillary whole blood; used by trained patients/caregivers at home for oral anticoagulation therapy management. Device uses membrane-based dry-reagent test strips; membrane separates plasma from red cells; contains calcium and thromboplastin to initiate extrinsic pathway reactions. Thrombin generation monitored optically via rhodamine-110-based fluorescent substrate. Meter software analyzes fluorescence kinetics to calculate PT-equivalent parameter and INR. Output displayed to user for therapy monitoring; enables patient self-management of anticoagulation under physician direction.

Clinical Evidence

Performance data demonstrated that the AvocetpT-Home performs equivalently when used by trained lay users and healthcare professionals. Both user groups generated results equivalent to an established reference method.

Technological Characteristics

Membrane-based dry-reagent system; optical fluorescence detection using rhodamine-110-based substrate. Measures prothrombin time via extrinsic pathway kinetics. Software-controlled; citrated blood/plasma modes deactivated for home-use version. Standalone meter form factor.

Indications for Use

Indicated for quantitative prothrombin time (INR) testing of fresh capillary whole blood in patients undergoing oral anticoagulation therapy. Intended for use by trained patients or caregivers under physician prescription.

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

• AvocetpT System (K991286)

Submission Summary (Full Text)

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K991286

## Attachment F 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. |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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- Avocet Medical, Inc. 1. Submitter's name 100 Great Oaks Blvd. Suite A address, contact San Jose, CA 95119 [phone] (phone) [phone] (fax)
Contact person: Judith Blunt

Date prepared: April 13, 1999

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

Trade or Proprietary Name: AvocetpT-Home

- 3. Predicate device: The AvocetpT System: device for testing Prothrombin Time and INR in whole blood.
The Avoceter-Home is a membrane-based, dry-reagent 4. Device description: system for use with fresh capillary whole blood. The system uses a 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 prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value. The AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.

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- 5. Intended use: The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). The AvocetpT-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
- The Avoceter-Home is substantially equivalent in 6. Comparison to materials, design and intended use to other products predicate device that measure Prothrombin Time INR in human blood. Most notably, it is substantially equivalent to the Avocet вт. manufactured by Avocet Medical Incorporated. In fact, it is identical in materials, design and function to the Avoceter, but the labeling has been changed for physician directed, home use.
- The AvocetpT.Home System was found to perform 6. Summary of performance data equivalently when used by trained lay users and healthcare professionals. Furthermore, both user populations generated results found to be equivalent to an established reference method.

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Nov 1 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jill Falcone Vice President of Regulatory Affairs and Quality Assurance AVOCET Medical Incorporated 100 Great Oaks Boulevard San Jose, California 95119-1347

K991286 Re: Trade Name: Avocet AcuSure System Regulatory Class: II Product Code: GJS Dated: October 22, 1999 Received: October 25, 1999

Dear Ms. Falcone:

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 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 (Premarket Approval), 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 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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## Page 2

Under Section 522 (a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA, are required to conduct postmarket surveillance studies. The FDA believes that under Section 522 (a) (2), discretionary postmarket surveillance will be in order for the Avocet AcuSure System. Please contact Valerie Dada at [phone] within 15 days of receipt of this letter, to arrange a meeting to discuss the objectives and design of a future discretionary postmarket surveillance study.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(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/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

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## Attachment G Premarket Notification Indications for Use Statement

Device Name: AvocetpT-Home

Indications for Use:

The Avoceter-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

Peter E. Makin

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

Prescription ✓

000268