BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

K043007 · Hyphen Biomed · JBQ · Nov 7, 2005 · Hematology

Device Facts

• Record ID: K043007
• Device Name: BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
• Applicant: Hyphen Biomed
• Product Code: JBQ · Hematology
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Device Story

Biophen Antithrombin 2.5 and 5 is an in vitro diagnostic assay for measuring Antithrombin concentration in human plasma. Used in clinical laboratory settings to assist in diagnosing thrombophilia resulting from congenital or acquired Antithrombin deficiency. The device utilizes a chromogenic assay principle to quantify Antithrombin levels. Results are provided to clinicians to monitor patient Antithrombin status and inform clinical decisions regarding recurrent thrombosis management.

Clinical Evidence

Bench testing only. Performance compared to Coamatic Antithrombin using 21 human plasma samples on automated BCS analyzers; correlation coefficient of 0.99. Reproducibility assessed on ACL analyzers; intra-assay CVs ranged from 0.66% to 0.92% and inter-assay CVs ranged from 2.49% to 3.72% across variable Antithrombin concentrations.

Technological Characteristics

In vitro diagnostic chromogenic assay for Antithrombin quantification. Operates on automated clinical chemistry analyzers (e.g., BCS, ACL).

Indications for Use

Indicated for the quantitative determination of Antithrombin in human plasma to aid in the diagnosis of thrombophilia (congenital Antithrombin deficiency).

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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# Section Q. Biophen Antithrombin - 510(k ) Summary (Summary of Safety and Effectiveness)

#### Submitted by:

Hyphen Biomed 95000 Neuville sur oise. France Phone # [phone] Fax# [phone]

# Contact Person:

Dr. Jean Amiral, President & Scientific Director

#### Summary prepared by:

14" Oct 2004

#### Name of the Device:

Biophen Antithrombin

Classification Name:

Antithrombin III Assay, Class II

Regulation # 864.7060

Product Code: 81JBQ

# Identification of Predicate device:

K 915083 Coamatic ® Antithrombin ( Originaly named Coamatic Antithrombin)

# Description of the Device/Intended use:

Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.

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

Biophen Antithrombin uses the same principle as the predicate Coamatio® Antithrombin and is substantially equivalent in performance, intended use and safety and effectiveness.

#### Summary of performance Data:

The assay performance of Biophen Antithrombin was compared to Coamatic ® Antithrombin using plasma received from hospital on automated BCS. The Biophen Antithrombin ®2.5 & 5 રવ 510(k) # K043007

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correlation was 0.99 between the results obtained with the two devices. Overall 21 samples were tested on both the devices.

The intra-assay and Inter assay reproducibility's obtained for samples with variable Antithrombin concentration on ACL is given below:

| sample | AT concentration<br>% | Intra Assay<br>(CV %) | N | Inter-Assay<br>(CV %) | N |
|--------|-----------------------|-----------------------|----|-----------------------|----|
| 1 | 109 | 0.73% | 10 | 2.57% | 12 |
| 2 | 69 | 0.66% | 10 | 2.49% | 12 |
| 3 | 51 | 0.92% | 10 | 3.72% | 12 |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle.

NOV - 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HYPHEN Biomed c/o Mr. Ola Anderson President Aniara Corporation 6560 Gove Court Mason, Ohio 45040

Re: k043007

> Trade Name: Biophen® Antithrombin 2.5 and Biophen® Antithrombin 5 Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBQ Dated: September 14, 2005 Received: September 15, 2005

Dear Mr. Anderson:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 adultcration.

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). 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.

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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). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): 043007

Device Name: Biophen ® Antithrombin 2.5 &5

Indications for Use:

BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrepes of CDRH, Office of Device Eyaluation (ODE)

Josephine Bautista

Division/Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K043007