IL TEST ANTITHROMBIN

K980499 · Instrumentation Laboratory CO · JBQ · Apr 2, 1998 · Hematology

Device Facts

• Record ID: K980499
• Device Name: IL TEST ANTITHROMBIN
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

IL Test™ 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).

Device Story

IL Test™ Antithrombin is an in vitro diagnostic reagent for quantitative measurement of Antithrombin in human plasma. Used in clinical laboratory settings to monitor heparin administration during thrombosis treatment and assist in diagnosing congenital thrombophilia. Operates via standard coagulation analyzer platforms (ACL 300, ACL Futura). Provides quantitative results to healthcare providers to guide anticoagulant therapy and assess coagulation status.

Clinical Evidence

Method comparison study of 52 plasma samples comparing IL Test™ Antithrombin on ACL 300 and ACL Futura against predicate Coamatic® Antithrombin on Cobas Mira. Correlation (r) was 0.992 and 0.991 respectively. Within-run precision (CV) ranged from 1.6% to 3.9% across two levels of sample activity.

Technological Characteristics

In vitro diagnostic reagent for quantitative Antithrombin assay. Utilizes same test principle as predicate. Designed for use on automated coagulation analyzers (ACL 300, ACL Futura).

Indications for Use

Indicated for quantitative determination of Antithrombin in human plasma to monitor heparin therapy for thrombosis and aid in diagnosis of congenital thrombophilia.

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

• Coamatic® Antithrombin (K915083)

Submission Summary (Full Text)

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K980499

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

#### Submitted by:

APR - 2 1998

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax:

Contact Person:

Carol Marble Phone: [phone]

Summary Prepared:

February 6, 1998

#### Name of the device:

IL Test™ Antithrombin

## Classification name(s):

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

## Identification of predicate device(s):

Coamatic® Antithrombin (originally named Coamate Antithrombin) K915083

#### Description of the device/intended use(s):

IL Test™ 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).

## Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

The new IL Test™ Antithrombin uses the same test principle as the predicate Coamatic® Antithrombin and is substantially equivalent in performance, intended use and safety and effectiveness.

## Summary of Performance Data:

In method comparison studies evaluating 52 plasma samples, the correlation (r) was 0.992 for the new IL Test™ Antithrombin on the ACL 300 as compared to the predicate Coamatic® Antithrombin on the Cobas Mira and 0.991 for the new IL Test™ Antithrombin on the ACL Futura as compared to the predicate Coamatic® Antithrombin on the Cobas Mira.

On the ACL 300, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.6% (at a mean of 49.2% activity) and 1.6% (at a mean of 103.7% activity). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.9% (at a mean of 48.7% activity) and 3.0% (at a mean of 104.5% activity).

Page 1 of 1 IL Test™ Antithrombin 510(k) Section 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 2 1998

Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

K980499 Re : IL Test™ Antithrombin Regulatory Class: II Product Code: JBO Dated: February 6, 1998 Received: February 9, 1998

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 legally 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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): _ H980499

Device Name: IL Test™ Antithrombin

## Indications for Use:

IL Test™ 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).

(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. K980499

Prescription Use
(Per 21 CFR 801.019)

OR Over-The-Counter Use _

Over-The-Counter Use

Section 2

IL Test™ Antithrombin 510(k)

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