HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Device Description

AI/ML Overview

This 510(k) submission (K070301) for HemosIL Antithrombin is a re-submission to modify the "Expected Values" section of the product insert. It explicitly states that the device itself is not materially different from the previously FDA-cleared predicate device (K980499 HemosIL Antithrombin).

Therefore, this document does not contain a new study demonstrating the device meets acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device, whose previous clearance would have involved studies meeting acceptance criteria. The information provided is primarily focused on the regulatory process for a labeling change, rather than a new performance study.

Given this, I cannot provide a detailed answer to your request in the format you specified, as the document does not contain the required information about a new performance study.

However, I can extract the following information that is present in the provided text:

Device Name: HemosIL Antithrombin
Intended Use: Quantitative determination of Antithrombin in human plasma to monitor heparin administration in thrombosis treatment and as an aid in diagnosing thrombophilia (congenital Antithrombin deficiency).
Regulatory Information:
- Regulation Number: 21 CFR 864.7060
- Regulation Name: Antithrombin III Assay
- Product Code: JBQ
- Regulatory Class: Class II
Predicate Device: K980499 HemosIL Antithrombin
Reason for Submission: Modification of the "Expected Values" section in the product insert to reference published literature and emphasize the need for each laboratory to establish its own normal range.
Statement on Technological Characteristics: "HemosIL Antithrombin with the modified Expected Values section in the product insert is not materially different from the FDA cleared device."
Expected Values (Modified Section): "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." This section references: Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336.

To answer your request, one would need to access the original 510(k) submission for the predicate device (K980499 HemosIL Antithrombin), as that is where the performance data and acceptance criteria would have been established and demonstrated. This current document does not provide any of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set size, etc.) because it is not a submission for a new device or significant modification requiring new performance data.

Summary

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510(k) Summary HemosIL Antithrombin

K07030/

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:

January 30, 2007

Name of the Device:

HemosIL Antithrombin

Regulatory Information:

864.7060 Antithrombin III Assay 81JBQ Antithrombin III Quantitation

Identification of Predicate Device(s):

K980499 HemosIL Antithrombin

Device Description:

Hemos L. Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenttal deficiency of Antithrombin).

Class II

Reason for Submission:

The Expected Values section of the HemosIL Antithrombin insert is 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 Antithrombin with the modified Expected Values section in the product insert 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.
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FEB 2 3 2007

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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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

INSTRUMENTATION LABORATORY C/O Carol Marble 101 Hartwell Avenue Lexington, Massachusetts 02421

Re: K070301

Trade/Device Name: HemosIL Antithrombin Regulation Number: 21 CFR 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: Class II Product Code: JBQ Dated: January 30, 2007 Received: January 31, 2007

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.

FEB 2 3 2007

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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

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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 Compliance at (240) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert R. Boakef

Robert L. Becker, Jr., MD, PhD 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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HFZ-404 510(k) Staff HFZ- 440 Division

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Indications for Use Statement

510(k) Number (if known): K070301

Device Name: HemosIL Antithrombin

Indications for Use:

HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

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 (OTVD)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Special 510(k): HemosIL Antithrombin

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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).