BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

K043451 · Hyphen Biomed · GGN · Mar 17, 2005 · Hematology

Device Facts

• Record ID: K043451
• Device Name: BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
• Applicant: Hyphen Biomed
• Product Code: GGN · Hematology
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Biophen plasma calibrator is used as a calibrator in the assay for the Antithrombin III & Protein C. It can be also used as normal human plasma control. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.

Device Story

Biophen Plasma Calibrator, Normal Control Plasma, and Abnormal Control Plasma are lyophilized, citrated human plasma products. Used as calibrators and quality control materials in clinical coagulation laboratories. Reconstituted with distilled water before use. Analyzed via mechanical or photo-optical coagulation instrumentation. Provides reference values for ATIII, Protein C, and Lupus Anticoagulant assays. Ensures accuracy and precision of coagulation testing by providing standardized control points for clinical decision-making regarding hemostasis and thrombosis risk.

Clinical Evidence

No clinical data. Bench testing only. Device performance is validated through established coagulation assay parameters (ATIII, Protein C, Lupus Anticoagulant) and APC resistance ratios (≥2.00 for Normal Control).

Technological Characteristics

Lyophilized citrated normal human pooled plasma (>75%). Additives: Hepes (<10 mg), Glycine (<25 mg), Ciprofloxacin (<0.001%). Reconstituted with 1 ml distilled water. Form factor: 12 vials. No electronic or software components.

Indications for Use

Indicated for use as calibrators and quality control materials for coagulation assays measuring Antithrombin III (ATIII), Protein C, and Lupus Anticoagulant in human plasma samples.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Plasma Control N (K001256)
• Lyphochek Hemostasis Control (K020878)

Submission Summary (Full Text)

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K043451/

# Summary Report For Biophen Plasma Calibrator

#### Description:

BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, BIOPHEN Plasma Calibrator leagent is compose of each it contains 12 vials
lyophilised in the presence of additives and presentives unter lyophillsed in the presente of adultived with 1 ml distilled water.
of lyophilised reagent to be reconstituted with 1 ml distilled water.

Proprietary Name: Biophen Plasma Calibrator

Established Name: Plasma Calibrator

#### Intended use:

The Biophen plasma calibrator is used as a calibrator in the assay for the The Blophen plasma Calibrator is used as a callerator in the accorporation III & Protein C. It can be also used as normal human plasma control.

The following table shows various parameters, which are measured using the assays The lollowing table shows various paramoters, while waskage inserts:

| Assays | Reagents | Manufacturers | Reference |
|---------------|----------------------|---------------|-----------|
| ATIII | Biophen | Hyphen Biomed | 221102 |
| | Antithrombin | | 221105 |
| Protein C | Biophen Protein<br>C | Hyphen Biomed | 221202 |
| | | | 221205 |
| Lupus | DWtest® | American | 810 |
| Anticoagulant | DWconfirm® | Diagnostica | 815/815L |

DWtest, DWconfirm are registered trade marks from American Diagnostica Inc.

The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.

# Matrix Base: Stabilized reagent from human plasma

Form: Lyophilized

Volume: 1ml per vial

#### Composition:

Normal human citrated pooled plasma: Freeze dried powder containing human plasma >75% Hepes <10 mg Glycine < 25 mg Ciprofloxacin <0.001%

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# Biophen Normal and Abnormal Control Plasma 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 [e-mail]

### Summary prepared by:

16th November 2004

#### Name of the device:

Biophen Normal Control Plasma & Biophen Abnormal Control Plasma

#### Classification Name:

Plasma Controls, Normal and Abnormal

Regulation#: 864.5425

# Predicate Device Information:

Plasma Control N (K001256) for Biophen Normal Control Plasma 1 Jaama Control (K020878) for Biophen Abnormal Control Control Plasma

#### Description of the Device/intended use:

Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.

The following table shows the various parameters which are measured using assays The lollowing table shows the varieting to be as per the package inserts.

| Assays | Reagents | Manufacturers | Reference |
|------------------------|-----------------------|-------------------------|------------------|
| ATIII | Biophen ATIII | Hyphen Biomed | 221102<br>221105 |
| Protein C | Biophen Protein C | Hyphen Biomed | 221202<br>221205 |
| Lupus<br>Anticoagulant | DWtest®<br>DWconfirm® | American<br>Diagnostica | 810<br>515/815L |

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The Biophen Normal and Abnormal Control Plasma are tested for the absence of The Diophen Normal and Abhormsed as a negative control for this investigation.

The Normal control plasma is also tested for the absence of Activated Protein C The Normal Control plasma is also tostos no formed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥2.00.

# Statement of how the technological Characteristics of the device compare to the Predicate device:

Biophen Normal control uses the same principle as the predicate Control Plasma N Diophen Normal oonlive about the performance, intended use and safety and effectiveness.

Biophen Abnormal control uses the same principle as the predicate Lyphockek®Hemostasis Control and is substantially equivalent in performance, intended use and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

MAR 17 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HYPHEN Biomed c/o Mr. Ola Anderson President Aniara 9944 Benningtan Drive Cincinnati, Ohio 45241

Re: k043451

Trade/Device Name: Biophen Normal Control Plasma, Biophen Abnormal Control Plasma and Biophen Plasma Calibrator

Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose Systems for In Vitro Coagulation Studies Regulatory Class: II Product Code: GGN Dated: February 14, 2005 Received: February 16, 2005

Dear Mr. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regions and ment date of the Medical Device Amendments, or to conimer of pror to 112) 20, 2011 de nocs that have t (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 I ou may, alex of ovisions of the Act include requirements for annual registration, listing of general ocharely proficturing 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 11 your device is elabilitional 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 or any I 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 Of N Far 807), 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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Page 2 -

If you desire specific information about the application of labeling requirements to your device, If you destre specific infortion and advertising of your device, please contact the Office of In of quotions on are promise 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 Tou may other belief geturers, 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,

lobatz Beckerh

Robert L. Becker, Jr., MD, PM. 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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#### Indication for use

510(k) number: K043451

Device Name: Biophen Plasma Calibrator

Indication for Use:

Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in Blophen Flaoma Cafer coagulation factors Antithrombin III and Protein C.

The following table shows various parameters which are measured using the assays from Hyphen BioMed or from other manufacturers as per the instructions in the package insert:

| Assays | Reagents | Manufacturers | Reference |
|------------------------|-----------------------|-------------------------|-----------------|
| ATIII | Biophen | Hyphen Biomed | 221102 |
| | Antithrombin | | 221105 |
| Protein C | Biophen Protein C | Hyphen Biomed | 221202 |
| | | | 221205 |
| Lupus<br>Anticoagulant | DWtest®<br>DWconfirm® | American<br>Diagnostica | 810<br>815/815L |

DWtest, DWconfirm are registered trade marks from American Diagnostica Inc.

The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.

Prescription Use
(Part 21 CFR 801 Subpart D)

And/or Over -The Counter use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista

Page 1 of 1

Off nostie

sva

5100( K043451 5

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# Indications for Use

510(k) Number (if known): 043451

# Device Name: Biophen Normal Control Plasma & Biophen Abnormal Control Plasma

#### Indications for Use:

Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal Blophen Normal and Abhoma. Och er ontrol of some coagulation factors.

The following table shows the various parameters which are measured using assays. The following table shows the various puramotors which while waskage inserts:

| Assays | Reagents | Manufacturers | Reference |
|------------------------|-----------------------|-------------------------|------------------|
| ATIII | Biophen ATIII | Hyphen Biomed | 221102<br>221105 |
| Protein C | Biophen Protein C | Hyphen Biomed | 221202<br>221205 |
| Lupus<br>Anticoagulant | DWtest®<br>DWconfirm® | American<br>Diagnostica | 810<br>815/815L |

DWtest, DWconfirm are registered trade marks from American Diagnostica Inc

The Biophen Normal and Abnormal Control Plasma are tested for the absence of The Diophen Normal and Abhormand as a negative control for this investigation.

This control plasma is also tested for the absence of Activated Protein C resistance This control plasma is also tested for the about without Activated Protein C (APC), (Acc + 3 1): the ratio obtained (APTT + APC/APTT) is ≥ 2.00 for the Normal Control Plasma.

Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Angelina Bautista

Page 1 of 1

**Divisiof**

Office V
Evalu

510(k)_K043451