IL TEST LIQUID ANTITHROMBIN

K994238 · Instrumentation Laboratory CO · JBQ · Jun 23, 2000 · Hematology

Device Facts

• Record ID: K994238
• Device Name: IL TEST LIQUID ANTITHROMBIN
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Jun 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

IL Test™ 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. 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

Automated chromogenic assay for quantitative Antithrombin measurement in human citrated plasma; utilizes synthetic chromogenic substrate and Factor Xa inactivation; specific for Antithrombin, unaffected by Heparin Cofactor II. Used in clinical laboratory settings on IL Coagulation Systems (e.g., ACL 6000, ACL Futura); operated by laboratory technicians. Output is a quantitative Antithrombin activity level; assists clinicians in diagnosing hereditary or acquired Antithrombin deficiency.

Clinical Evidence

Bench testing only. Method comparison study evaluated 118 citrated plasma samples (40 normal, 78 abnormal) on ACL 6000 and ACL Futura systems. Results showed strong correlation with predicate (r=0.995 for ACL 6000; r=0.994 for ACL Futura). Within-run precision (%CV) ranged from 2.10% to 12.10% across normal and abnormal control levels.

Technological Characteristics

Automated chromogenic assay; utilizes synthetic chromogenic substrate and Factor Xa inactivation. Designed for use on IL Coagulation Systems. Quantitative measurement of Antithrombin activity.

Indications for Use

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

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).

Predicate Devices

• IL Test™ Antithrombin (K980499)

Submission Summary (Full Text)

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994238

# Section 3 IL Test™ Liquid Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

# Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax:

### Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: [phone] / Fax: [phone]

### Summary Prepared:

December 15, 1999 (Revised April 11, 2000)

### Name of the Device:

IL Test™ Liquid Antithrombin

# Classification Name(s):

| 864.7060 | Antithrombin III Assay | Class II |
|----------|-------------------------------|----------|
| 81JBQ | Antithrombin III Quantitation | |

# Identification of Predicate Device(s):

K980499 IL Test™ Antithrombin

### Description of the Device/Intended use(s):

IL Test™ 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.

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.

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

IL Test™ Liquid Antithrombin uses the same test principle as the predicate device (IL Test™ Antithrombin) and is substantially equivalent in performance, intended use and safety and effectiveness.

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# Section 3 IL Test™ Liquid Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

#### Summary of Performance Data:

#### Method Comparison

In method comparison studies evaluating 118 citrated plasma samples (40 normals and 78 abnormals) on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ Liquid Antithrombin versus the predicate device are shown below:

| New Device vs. Predicate Device | | |
|---------------------------------|-------|-------|
| IL System | Slope | r |
| ACL 6000 | 0.99 | 0.995 |
| ACL Futura | 1.01 | 0.994 |

### Within Run Precision

Within run precision assessed over multiple runs using three levels of control plasma gave the following results:

| | | Normal | Abnormal | Abnormal |
|-------------------|-------|--------|----------|----------|
| ACL 6000 | Level | Level | Level I | Level II |
| Mean (% Activity) | | 102.6 | 53.6 | 22.1 |
| % CV | | 2.54 | 3.27 | 7.54 |
| ACL Futura | Level | Level | Level I | Level II |
| Mean (% Activity) | | 104.6 | 54.2 | 25.2 |
| % CV | | 2.10 | 2.47 | 12.10 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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# JUN 2 3 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Manager, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421

Re: K994238

> Trade Name: IL Test™ Liquid Antithrombin Regulatory Class: II Product Code: JBQ Dated: April 11, 2000 Received: April 12, 2000

Dear Ms. Marble:

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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This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to obegin mantening , puivalence of your device to a legally marketed noutleation. The FDF Intentig of castion 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 II you desire specific advices), please contact devices), please contact the Office of Compliance at additionally 007.10 for mintes are questions on the promotion and advertising of your device, [phone]. Truditionally, for quest at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsionnes and institute and more [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/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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# Indications for Use Statement

# 510(k) Number (if known): 994238

Device Name: IL Test™ Liquid Antithrombin

### Indications for Use:

IL Test™ 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.

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.

### (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 | K994238 |

| Prescription Use (Per 21 CFR 801.019) | | OR | Over-The-Counter Use | |
|---------------------------------------|--|----|----------------------|--|
|---------------------------------------|--|----|----------------------|--|

Section 2 IL Test™ Liquid Antithrombin 510(k) Page 1 of 1