COAMATIC AT-400

K022195 · Instrumentation Laboratory CO · JBQ · Aug 7, 2002 · Hematology

Device Facts

• Record ID: K022195
• Device Name: COAMATIC AT-400
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Aug 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. 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 10-125% of normal plasma.

Device Story

Coamatic® AT-400 is an in vitro diagnostic assay for measuring antithrombin (AT) activity in human citrated plasma. The assay functions by incubating plasma with excess Factor Xa (FXa) and heparin; AT in the sample inhibits FXa. Residual FXa activity is measured via the rate of hydrolysis of chromogenic substrate S-2772, with pNA release detected spectrophotometrically at 405 nm. The measured rate is inversely proportional to the AT level (range 10-125%). Used in clinical laboratory settings by trained personnel, the output provides quantitative AT levels to assist clinicians in evaluating coagulation status and thrombosis risk. The device aids in identifying deficiencies in the natural coagulation inhibitor system.

Clinical Evidence

Method comparison study of 61 citrated plasma samples (range 10.4-125% AT activity) comparing Coamatic® AT-400 on ACL Futura to predicate IL Test™ Antithrombin on ACL 9000 showed a correlation coefficient (r) of 0.995, slope of 0.9810, and intercept of 4.9773. Precision assessed at three levels (113%, 59%, 31% AT) showed total CV% ranging from 2.81% to 4.76%.

Technological Characteristics

Chromogenic enzymatic assay. Reagents: Factor Xa, heparin, and chromogenic substrate S-2772. Detection: Spectrophotometric measurement at 405 nm. System: Designed for use on automated coagulation analyzers (e.g., ACL Futura).

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™ Antithrombin (K980499)

Submission Summary (Full Text)

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K022195

# AUG 0 7 2002

## Section 3 Coamatic® AT-400 - 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:

July 3, 2002

### Name of the Device:

Coamatic® AT-400

### 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):

Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.

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 10-125% of normal plasma.

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

Coamatic® AT-400 is substantially equivalent in performance to the predicate device: IL Test™ Antithrombin

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## Section 3 Coamatic® AT-400 - 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 10.4 to 125% AT activity, the correlation statistics for Coamatic® AT-400 on an ACL Futura versus the predicate device on an ACL 9000 are shown below:

| System | Slope | Intercept | r | Reference Method |
|------------|--------|-----------|-------|----------------------------------------|
| ACL Futura | 0.9810 | 4.9773 | 0.995 | IL Test TM Antithrombin 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 |
| 113 | 1.80 | 6 | 2.81 | 60 |
| 59 | 2.64 | 6 | 3.23 | 60 |
| 31 | 4.52 | 6 | 4.76 | 60 |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 0 7 2002

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: k022195

> Trade/Device Name: Coamatic® AT-400 Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBQ Dated: July 3, 2002 Received: July 5, 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 (OS) 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 Butman

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® AT-400

### Indications for Use:

Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.

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 10-125% 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 |

| 510(k) Number | K022195 |
|---------------|---------|
|---------------|---------|

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

| Section 2 | Coamatic® AT-400 510(k) | Page 1 of 1 |
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