BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

K050367 · Hyphen Biomed · KFF · May 24, 2006 · Hematology

Device Facts

• Record ID: K050367
• Device Name: BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
• Applicant: Hyphen Biomed
• Product Code: KFF · Hematology
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7525
• Device Class: Class 2

Intended Use

The Hyphen Biomed Biophen Heparin 6 and Biophen Heparin 3 are chromogenic assays for measuring the quantitative level of unfractionated heparin in human citrated plasma using an automatic or manual method.

Device Story

Biophen Heparin 6 and 3 are chromogenic assays for quantitative measurement of unfractionated heparin in human citrated plasma. The device utilizes a two-stage Factor Xa (FXa) inhibition method. Input: citrated plasma sample. Principle: Heparin in the sample inhibits a constant amount of bovine FXa in the presence of endogenous antithrombin; residual FXa hydrolyzes a specific chromogenic substrate (SXa-11), releasing pNA. Output: pNA concentration measured at 405 nm via spectrophotometry; absorbance is inversely proportional to heparin level. Used in clinical laboratory settings; operated by laboratory technicians. Results assist clinicians in monitoring heparin therapy and adjusting dosages.

Clinical Evidence

No clinical data provided; device performance is established through analytical bench testing for in vitro diagnostic assays.

Technological Characteristics

In vitro diagnostic reagent kit for anti-factor Xa activity measurement. Utilizes chromogenic or clotting-based assay principles (implied by anti-FXa methodology). Compatible with standard clinical laboratory automated analyzers or manual spectrophotometric/coagulation instrumentation. No specific materials of construction or software algorithms described beyond standard laboratory assay protocols.

Indications for Use

Indicated for quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma for patients undergoing heparin therapy to monitor drug levels and adjust dosage.

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).

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

ﺳﺔ

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 4 2006

HYPHEN BIOMED C/O Aniara Ola Anderson 6560 Gove Court Mason, Ohio 45040

Re: k050367

Trade/Device Name: BIOPHEN Heparin 3, BIOPHEN Heparin 6 Regulation Number: 21 CFR 864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF Dated: 12 May 2006 Received: 16 May 2006

## Dear: Mr. Anderson

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

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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. 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

Robert Becker

Robert L. Becker, Jr., MD, PH.D 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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# Section D. Statement of Indication for Use

510 (k) Number: 050367

### Device Name: Biophen Heparin 3 Biophen Heparin 6

### Indications for use:

Biophen Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma using automated or manual methods. The nopant of UFH is determined from the Anti factor Xa (anti-FXa) activity expressed by the [AT* Heparin] complex formed in plasma.

Heparin is used for curative or preventive indications. Measuring Heparin concentration in patient's plasma allows monitoring therapy and adjusting drug dosage.

Prescription Use V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050367

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