CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

K023991 · Precision Biologic · JBQ · Apr 28, 2003 · Hematology

Device Facts

• Record ID: K023991
• Device Name: CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
• Applicant: Precision Biologic
• Product Code: JBQ · Hematology
• Decision Date: Apr 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

Device Story

ChromoCheck™ Antithrombin is an in vitro diagnostic chromogenic assay used to quantify antithrombin activity in citrated human plasma. The device utilizes a synthetic chromogenic substrate and bovine Factor Xa in a Tris Heparin buffer. The assay functions by measuring the inhibition of Factor Xa by antithrombin in the presence of heparin; the residual Factor Xa cleaves the synthetic substrate, producing a color change proportional to the antithrombin activity. The assay is performed in a clinical laboratory setting by trained laboratory personnel. Results are reported as a percentage of antithrombin activity, which assists clinicians in evaluating patient coagulation status and diagnosing antithrombin deficiencies.

Clinical Evidence

Bench testing only. A correlation study was conducted comparing two lots of ChromoCheck™ Antithrombin against the Coamatic® Antithrombin predicate using 50 normal and pathological patient samples. Results showed strong correlation with R2 values of 0.992 and 0.989, slopes of 0.988 and 1.036, and y-intercepts of 1.389 and -2.095, respectively.

Technological Characteristics

Chromogenic assay consisting of synthetic substrate, bovine Factor Xa, and Tris Heparin buffer. Provided in lyophilized format for reconstitution with distilled water and buffer. Quantitative measurement based on enzymatic inhibition principle.

Indications for Use

Indicated for the quantitative determination of antithrombin activity in citrated human plasma for patients requiring assessment of antithrombin levels.

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 (K022195)

Submission Summary (Full Text)

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# 510(K) Summary ChromoCheck™ Antithrombin

# This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 1402399 |

| Submitters Name &<br>Address: | Precision BioLogic Incorporated<br>900 Windmill Road, Suite 100<br>Dartmouth, Nova Scotia B3B 1P7<br>Canada |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Stephen L. Duff - Director of New Business<br>Development<br>Phone: [phone] ext. 224<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | November 29, 2002 |
| Device Name &<br>Classification: | ChromoCheck™ Antithrombin<br>Common Name: Antithrombin chromogenic assay<br>Classification Name: Antithrombin quantitation<br>Regulatory Class II, 81 JBQ |
| Predicate Device: | Chromogenix AB/ Instrumentation Laboratory<br>Taljegardsgatan 3<br>S-431 53 Molndal<br>Sweden, SW |
| Device Description: | ChromoCheck™ Antithrombin is a chromogenic<br>assay consisting of a synthetic substrate, Factor Xa,<br>and a Tris Heparin Buffer |
| Device Intended Use: | ChromoCheck™ Antithrombin is intended for use as<br>a chromogenic assay for the quantitative<br>determination of antithrombin activity in citrated<br>human plasma. |

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| Parameter | ChromoCheckTM Antithrombin | Coamatic Antithrombin |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Antithrombin quantitation | Antithrombin quantitation |
| Analytes | Antithrombin | Antithrombin |
| Component<br>Reagent<br>Matrices | Reagent 1: Chromogenic substrate in a<br>distilled water matrix<br>Reagent 2: Factor Xa - Bovine Factor<br>Xa in a Tris Heparin Buffer matrix<br>Reagent 3: Tris Heparin Buffer | Reagent 1: Chromogenic substrate in a<br>distilled water matrix<br>Reagent 2: Factor Xa - Bovine Factor<br>Xa in a Tris Heparin Buffer matrix<br>Reagent 3: Tris Heparin Buffer |
| Format | Lyophilized | Lyophilized |
| Packaging | 4 x Substrate (3.75 mg)<br>4 x Factor Xa (5 µg)<br>4 x 5 mL Tris Heparin Buffer<br>(Reconstituted volume - 2.5 mL)<br>4 x Substrate (3.75 mg)<br>4 x Factor Xa (5 µg)<br>4 x 10 mL Tris Heparin Buffer<br>(Reconstituted volume - 5.0 mL) | 2 x Substrate S-2772 (26 mg)<br>6 x Factor Xa (90 nkat)<br>6 x Buffer with heparin (25 mL) |

## Comparison to Predicate Device:

## Comments on Substantial Equivalence:

It is the opinion of Precision BioLogic Inc. that ChromoCheck™ Antithrombin is substantially equivalent to Coamatic Antithrombin (K022195), manufactured by Chromogenix AB (originally Kabi Pharmacia, Inc.), and currently marketed in the United States by Instrumentation Laboratory. This opinion is based on the following:

- both devices are based on synthetic chromogenic substrates ■
- both devices contain Factor Xa from a bovine source I
- . Both devices contain lyophilized reagents
- Both devices consist of a substrate, which is reconstituted with distilled water, Factor Xa, I which is reconstituted with Tris Heparin Buffer, and Tris Heparin Buffer
- u Both devices are intended for use in the quantitative determination of antithrombin activity in citrated human plasma
- 피 Both devices present results as a % activity of antithrombin

#### Correlation:

Two lot numbers of ChromoCheck™ Antithrombin were compared to Coamatic® Antithrombin in a correlation study using a mix of 50 normal and pathological patient samples. The following correlation was achieved:

| Correlation<br>parameter | ChromoCheck<br>Antithrombin Lot 1 | ChromoCheck<br>Antithrombin Lot 2 |
|--------------------------|-----------------------------------|-----------------------------------|
| Y-intercept | 1.389 | -2.095 |
| Slope | 0.988 | 1.036 |
| R2 | 0.992 | 0.989 |

Conclusion: ChromoCheck™ Antithrombin is substantially equivalent to Coamatic® Antithrombin.

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Public Health Service

APR 2 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen L. Duff Director of New Business Development Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth, Nova Scotia Canada B3B 1P7

Re: k023991

> Trade/Device Name: ChromoCheck 114 Antithrombin Regulation Number: 21 CFR 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: Class II Product Code: JBQ Dated: March 26, 2003 Received: March 28, 2003

Dear Mr. Duff:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number:

ChromoCheck™ Antithrombin Device Name:

Koasgel

#### Indications for Use:

ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

Josephine Bautista

(Division Sign-Of Division of Clinical Laboratory Devices 510(k) Number

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