The AvocetpT 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 Description

The Avocetpr is a membrane-based, dry-reagent system for 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 prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value.

AI/ML Overview

The provided text describes the AvocetpT System, a device for measuring Prothrombin Time (INR). However, it does not contain explicit acceptance criteria in the format of a table with specific thresholds or targets (e.g., sensitivity > X%, specificity > Y%).

Instead, the acceptance criteria are implicitly stated through the claim of "substantial equivalence" to a predicate device and the outcomes of a performance study.

Here's an attempt to extract and infer the requested information based on the provided text:

AvocetpT System Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as stated in document)
Accuracy	Equivalent to CoaguChek™ and a reference method (r > 0.95)
Precision	Acceptable
Linearity	Acceptable
Interfering Substances	Results are reflected in the product labeling
Hematocrit	Results are reflected in the product labeling
RBC Abnormalities	Results are reflected in the product labeling
Factor Deficiencies	Results are reflected in the product labeling

Note: The document does not provide specific numerical thresholds for "acceptable" beyond the r > 0.95 for accuracy.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "field studies" for accuracy comparison.

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, "field studies" generally imply prospective data collection in a clinical setting.

3. Number of Experts and Qualifications for Ground Truth Establishment

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The comparison is made against a "reference method" and the predicate device (CoaguChek™), implying that the ground truth is established by these existing, presumably validated, methodologies, not necessarily by human expert interpretation of device raw output.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not explicitly stated. The study focuses on comparing the AvocetpT System's measurements against a reference method and a predicate device. There is no indication of human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This device is an in vitro diagnostic system that provides quantitative numerical results (INR). It does not involve human readers interpreting images or other data that would necessitate an MRMC study or AI-assistance in interpretation.

6. Standalone Performance Study

Standalone Performance: Yes, implicitly. The "accuracy of the AvocetpT was compared to the CoaguChek and a reference method in field studies." This indicates that the AvocetpT System's performance was evaluated as a standalone device without human-in-the-loop assistance in obtaining the INR output itself.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance evaluation appears to be established by:
- Measurements from a "reference method": This typically implies a well-established, highly accurate laboratory method for prothrombin time/INR.
- Measurements from the predicate device (CoaguChek™): Used for concordance and equivalence comparison.

8. Sample Size for the Training Set

Sample Size: Not applicable / Not stated. As an IVD device producing a direct quantitative measurement, it's unlikely to have a "training set" in the machine learning sense for its primary function. If there were internal calibration or algorithm development, details are not provided.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable / Not stated for a "training set." The device itself provides a direct measurement based on a biochemical reaction and optical detection, rather than a learned prediction from a dataset.

Summary

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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 408/374-7822

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 (408) 374-7262 (phone) (408) 374-7822 (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

1. 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 408/374-7822

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

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

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.
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.
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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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 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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	✓ OR Over-The-Counter Use ____
(Per 21 CFR 801.109)	(Optional Format 1-2-96

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.