COAMATIC HEPARIN

K983178 · Instrumentation Laboratory CO · KFF · Nov 3, 1998 · Hematology

Device Facts

• Record ID: K983178
• Device Name: COAMATIC HEPARIN
• Applicant: Instrumentation Laboratory CO
• Product Code: KFF · Hematology
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7525
• Device Class: Class 2

Intended Use

Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.

Device Story

Coamatic® Heparin is an in vitro diagnostic assay for measuring heparin activity in human citrated plasma. The device utilizes a synthetic chromogenic substrate and Factor Xa inactivation principle; heparin accelerates the inhibitory effect of antithrombin on coagulation proteases. The assay measures anti-FXa activity, which correlates to the concentration of UFH or LMWH. The test is performed on automated laboratory analyzers or microplate systems by clinical laboratory personnel. Results are used by healthcare providers to monitor heparin therapy. The device provides quantitative data to assist in clinical decision-making regarding antithrombotic drug management.

Clinical Evidence

Bench testing only. Comparative studies performed against IL Test™ Heparin on various platforms (Cobas Mira, Microplate, ACL 300, ACL Futura, MLA Electra, Sysmex 6000, AMAX, Hitachi 911/917) using patient samples treated with UFH and LMWH, as well as spiked normal/pooled plasmas. Correlation coefficients (r) ranged from 0.97 to 0.99. Precision data for the microplate method showed total %CVs ranging from 2.8% to 4.4% for UFH and LMWH concentrations of 0.4 and 0.7 IU/mL.

Technological Characteristics

In vitro diagnostic assay using synthetic chromogenic substrate and Factor Xa inactivation. Compatible with automated laboratory analyzers and microplate systems. Quantitative measurement of anti-FXa activity.

Indications for Use

Indicated for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma. For prescription use.

Regulatory Classification

Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

Predicate Devices

• IL Test™ Heparin (K980242)

Submission Summary (Full Text)

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NOV 3 1998

## Section 3 Coamatic® Heparin - 510(k) SUMMARY (Summary of Safety and Effectiveness)

#### Submitted by:

Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax: [phone]

#### Contact Person:

Carol Marble Phone: [phone] / Fax: [phone]

#### Summary Prepared:

September 10, 1998

#### Name of the device:

Coamatic® Heparin

#### Classification name(s):

| | 864.7525 | Heparin Assay | Class II |
|-------|----------|----------------|----------|
| 81KFF | | Assay, Heparin | |

#### Identification of predicate device(s):

IL Test™ Heparin K980242

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

Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods.

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

The new Coamatic® Heparin is based on a synthetic chromogenic substrate and Factor Xa inactivation, as is the predicate device: IL Test™ Heparin, and is substantially equivalent in its performance, intended use and safety and effectiveness.

#### Summary of Performance Data:

The results from comparative studies of Coamatic® Heparin on different methods vs. IL Test™ Heparin on an ACL 300 using samples from patients treated with UFH and LMWH are shown below:

| Application | n | Slope | Intercept | r |
|-------------|--------------------------|-------|-----------|-------------|
| Cobas Mira | 87 | 1.04 | -0.01 | 0.98 |
| Microplate | 70 | 1.00 | 0.02 | 0.97 |
| ACL 300 | 62 | 1.02 | 0.01 | 0.98 |
| ACL Futura | 113 | 0.97 | 0.01 | 0.97 |
| MLA Electra | 80 | 1.01 | 0.00 | 0.97 |
| Section 3 | Coamatic® Heparin 510(k) | | | Page 1 of 2 |

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#### Summary of Performance Data (Continued):

The results from additional comparative studies of Coamatic® Heparin on other methods vs. IL Test™ Heparin on an ACL 300 using normal plasmas and pooled plasmas spiked with UHF heparin are shown below:

| Application | n | Slope | Intercept | r |
|-------------|----|-------|-----------|------|
| Sysmex 6000 | 30 | 0.91 | 0.06 | 0.99 |
| AMAX | 30 | 0.97 | 0.03 | 0.99 |
| Hitachi 911 | 30 | 0.98 | 0.01 | 0.99 |
| Hitachi 917 | 30 | 1.00 | 0.02 | 0.98 |

Precision data summarized below was obtained with the microplate method using unfractionated heparin (UFH) and low molecular weight heparin (LMWH):

#### Microplate Method:

| | Within Run | Between Run | Total |
|--------------------|------------|-------------|-------|
| Mean Concentration | %CV | %CV | %CV |
| 0.7 IU/mL UFH | 2.8 | 1.2 | 2.8 |
| 0.4 IU/mL UFH | 3.4 | 1.5 | 3.7 |
| 0.7 IU/mL LMWH | 3.6 | 2.8 | 4.4 |
| 0.4 IU/mL LMWH | 2.4 | 2.3 | 3.2 |

NOTE: Instrument-specific precision results are available in the application sheets.

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September 8, 1998

Image /page/2/Picture/1 description: The image shows the logo for Instrumentation Laboratory. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is a stylized cube-like structure, and the text reads "Instrumentation Laboratory" in a bold, sans-serif font.

# PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT [AS REQUIRED BY 21 CFR 807.87(j)]

I certify that, in my capacity at Instrumentation Laboratory Company, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

William Wood
***Signature***

Signature

William Wood Name

IL Director of Regulatory Affairs/Quality Assurance Title 9 98 8

Date

K983178

---

Premarket Notification 510(k) Number

Coamatic® Heparin

ﺮ

Coamatic® Heparin 510(k)

Instrumentation Laboratory Company

Page 5 of 7 A CH-Werfen Company

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.

#### Public Health Service

#### 3 1998 NOV

Ms. Carol Marble Requlatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02173-3190

Re: K983178 Trade Name: Coamatic® Heparin Regulatory Class: II Product Code: KFF Dated: September 10, 1998 Received: September 11, 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 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 requlations affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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"(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/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

راني

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# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coamatic® Heparin

### Indications for Use:

Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.

Heparin is the most frequently used antithrombotic drug. The biological activity of this sulphated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory effect of antithrombin on coagulation proteases.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*E. Make*
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983778

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