HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

AI/ML Overview

This 510(k) submission (K062431) for HemosIL Liquid Antithrombin is a "Special 510(k)" which indicates that the device being submitted is not materially different from a previously cleared device. The purpose of this submission is to modify the "Expected Values" section of the product inserts to reference a normal range from published literature and reinforce the need for each laboratory to establish its own normal reference range.

Therefore, the submission does not contain new performance studies or data to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device (K033775 HemosIL Liquid Antithrombin) and the update to labeling information.

Because no new performance study data is presented, much of the requested information cannot be provided. However, based on the provided document, here's what can be inferred or explicitly stated:

Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a labeling change and not a new device or significant modification requiring new performance data, there are no specific acceptance criteria or reported device performance metrics presented in this document. The device relies on the performance validated for the predicate device, K033775 HemosIL Liquid Antithrombin.

Details of the Study

As this is a Special 510(k) for a labeling change, no new study proving device performance is included in this document. The submission focuses on updating the "Expected Values" section based on published literature and clarifying the need for local laboratory validation of normal ranges.

Therefore, the following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable, no new test set data presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no new ground truth established for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no new test set data presented.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is an in vitro diagnostic device, not an AI-assisted diagnostic product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is an in vitro diagnostic device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the predicate device, the ground truth would typically be established through method comparisons to recognized reference methods or clinical outcomes studies, but this information is not present in this document. The current submission updates expected values based on published literature.
The sample size for the training set: Not applicable, no new model training is performed.
How the ground truth for the training set was established: Not applicable, no new model training is performed.

Summary of Changes and Basis for Clearance:

The core of this submission is the modification of the "Expected Values" section in the product inserts. The change is:

From: Implied standard normal ranges.
To: Explicitly stating that "Antithrombin activity levels in healthy individuals are approximately in the range of 83 – 128%," and more importantly, adding the directive "Due to many variables which may affect results, each laboratory should establish its own normal range." This statement is supported by a published literature reference: "Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336."

The FDA's clearance (SEP - 1 2006) for this Special 510(k) indicates that they determined the device with this modified labeling is "substantially equivalent" to the previously cleared HemosIL Liquid Antithrombin (K033775). This is because the underlying device formulation and performance characteristics are unchanged, and the modification is limited to ensuring appropriate interpretation of results by emphasizing localized validation of reference ranges, a common best practice in clinical laboratory diagnostics.

Summary

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K062431

510(k) Summary HemosIL Liquid Antithrombin

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

Contact Person:

Carol Marble, Regulatory Affairs Director Phone No.: 781-861-4467 Fax No .: 781-861-4207

Summary Prepared:

August 17, 2006

Name of the Device:

HemosIL Liquid Antithrombin

Regulatory Information:

864.7060	Antithrombin III Assay
81JBQ	Antithrombin III Quantitation

Class II

Identification of Predicate Device(s):

K033775 HemosIL Liquid Antithrombin

Device Description:

Reason for Submission:

The Expected Values section of the HemosIL Liquid Antithrombin inserts (same formulation, different kit configuration size) are being modified to reference a normal range from published literature, reinforcing the need for each laboratory to establish its own normal [reference] range due to the many variables which may affect results.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL Liquid Antithrombin with the modified Expected Values section in the product inserts is not materially different from the FDA cleared device.

Summary of Expected Values Section to the Modified Product Insert:

Antithrombin activity levels in healthy individuals are approximately in the range of 83 – 128%. Antithrombin levels are low in neonates/infants and increase to adult levels by approximately 1. year of age; levels are then slightly higher than in adults up to age 16 year.*

Due to many variables which may affect results, each laboratory should establish its own normal range.

- Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336.
  Section 3

Special 510(k): HemosIL Liquid Antithrombin

SEP - 1 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

Re: K062431

Trade/Device Name: HemosIL Liquid Antithrombin Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin Regulatory Class: II Product Code: JBQ Dated: August 18, 2006 Received: August 21, 2006

Dear Ms. Marble:

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.

SEP - 1 2006

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 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.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobent Beckerh

Robert L. Becker, Jr., MD, PA 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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Indications for Use Statement

510(k) Number (if known): ___ |<0 62431

Device Name: HemosIL Liquid Antithrombin

Indications for Use:

This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa As a consequence, it is specific and not influenced by Heparin Cofactor II. inactivation. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista

Division Sign Off

Office of In Vitra Diagnostic Device Evaluation and Larsty

062431

Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).