COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS

K022550 · Instrumentation Laboratory CO · JBQ · Aug 27, 2002 · Hematology

Device Facts

• Record ID: K022550
• Device Name: COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Aug 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents). Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.

Device Story

Coamatic® LR Antithrombin is an in vitro diagnostic reagent kit for measuring antithrombin activity in human citrated plasma. The assay utilizes a chromogenic method: plasma is incubated with excess Factor Xa and heparin; residual Factor Xa hydrolyzes chromogenic substrate S-2772; pNA release is measured spectrophotometrically at 405 nm. The rate of pNA release is inversely proportional to antithrombin levels. The device is used in clinical laboratory settings on automated coagulation analyzers (e.g., ACL Futura). Healthcare providers use the quantitative output to evaluate antithrombin levels, which helps assess the patient's risk for uncontrolled coagulation and thrombosis.

Clinical Evidence

Bench testing only. Method comparison study evaluated 61 citrated plasma samples (range 8.6% to 121.5% AT activity) on an ACL Futura analyzer compared to the predicate on an ACL 9000, yielding a slope of 1.011, intercept of 0.4889, and r=0.995. Precision studies (n=60) showed total CV% ranging from 3.52% to 11.09% across three control levels.

Technological Characteristics

Liquid reagent kit for chromogenic antithrombin assay. Principle: Factor Xa inhibition assay using chromogenic substrate S-2772. Measurement: Spectrophotometric detection at 405 nm. Designed for use on automated coagulation analyzers.

Indications for Use

Indicated for the quantitative determination of heparin cofactor activity of antithrombin in human citrated plasma to assess coagulation cascade inhibition.

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™ Liquid Antithrombin (K994238)

Submission Summary (Full Text)

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# AUG 2 7 2002

IC022552

# Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

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

### Contact Person:

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

#### Summary Prepared:

August 1, 2002

#### Name of the Device:

Coamatic® LR Antithrombin

#### Classification Name(s):

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

## Identification of Predicate Device(s):

K994238 IL Test™ Liquid Antithrombin

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

Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).

Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.

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

Coamatic® LR Antithrombin is substantially equivalent in performance to the predicate device: IL Test™ Liquid Antithrombin

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# Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)

#### Summary of Performance Data:

### Method Comparison

In a method comparison study evaluating 61 citrated plasma samples with Antithrombin levels ranging in value from 8.6% to 121.5% AT activity, the correlation statistics for Coamatic® LR Antithrombin on an ACL Futura versus the predicate device on an ACL 9000 are shown below:

| System | Slope | Intercept | r | Reference Method |
|------------|-------|-----------|-------|---------------------------------|
| ACL Futura | 1.011 | 0.4889 | 0.995 | IL TestTM Liquid AT on ACL 9000 |

### Precision

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

| ACL Futura | | | | | |
|-------------|------------------|---|-------------|----|--|
| Mean (% AT) | CV% (Within run) | n | CV% (Total) | n | |
| 114 | 1.96 | 6 | 3.52 | 60 | |
| 59 | 6.21 | 6 | 6.43 | 60 | |
| 29 | 8.45 | 6 | 11.09 | 60 | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.

Food and Drug Administration 098 Gaither Road Rockville MD 20850

AUG 2 7 2002

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125

k022550 Re: Trade/Device Name: Coamatic® LR Antithrombin Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBO Dated: August 1, 2002 Received: August 2, 2002

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.

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.

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Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/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): ____________________________________________________________________________________________________________________________________________________

Device Name: Coamatic® LR Antithrombin

# Indications for Use:

Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).

Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.

#### (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 | K022550 |
| 510(k) Number | |

Prescription Use __________ OR Over-The-Counter Use __________

(Per 21 CFR 801.019)
Coamatic® LR Antithrombin 510(k)