HEMOSIL LIQUID ANTITHROMBIN

K062431 · Instrumentation Laboratory CO · JBQ · Sep 1, 2006 · Hematology

Device Facts

• Record ID: K062431
• Device Name: HEMOSIL LIQUID ANTITHROMBIN
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

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.

Device Story

HemosIL Liquid Antithrombin is an automated in vitro diagnostic assay for human citrated plasma. It utilizes a synthetic chromogenic substrate and Factor Xa inactivation to measure Antithrombin levels, ensuring specificity by avoiding interference from Heparin Cofactor II. The assay is performed automatically on IL Coagulation Systems in a clinical laboratory setting. Results are used by clinicians to diagnose Antithrombin deficiency and monitor substitution therapy. The device provides quantitative data to support clinical decision-making regarding patient coagulation status.

Clinical Evidence

No clinical data; bench testing only. The submission relies on literature-based reference ranges (Kottke-Marchant K, Duncan A. Arch Pathol Lab Med. 2002) to update the product labeling.

Technological Characteristics

In vitro diagnostic liquid assay for antithrombin. Modification is informational (labeling update) rather than physical or chemical. No changes to sensing principle or materials.

Indications for Use

Indicated for quantitative determination of Antithrombin in human citrated plasma to aid in diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

Regulatory Classification

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).

Submission Summary (Full Text)

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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:

1

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.

### 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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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 [phone]. 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 [phone] or [phone] 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:

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 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