FIBRINOGEN CALIBRATOR KIT

K994341 · Dade Behring, Inc. · GFX · Mar 3, 2000 · Hematology

Device Facts

• Record ID: K994341
• Device Name: FIBRINOGEN CALIBRATOR KIT
• Applicant: Dade Behring, Inc.
• Product Code: GFX · Hematology
• Decision Date: Mar 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Intended Use

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.

Device Story

Fibrinogen Calibrator Kit consists of lyophilized calibrators derived from pooled human plasma; donors selected for health; plasma diluted with buffered solution or supplemented with purified fibrinogen and stabilized. Used in clinical laboratory settings by laboratory professionals. Device serves as reference material to establish calibration curves for Clauss fibrinogen assays. Healthcare providers use these curves to quantify fibrinogen levels in patient samples, aiding in the assessment of coagulation status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human plasma-based calibrators; stabilized with buffered solution or purified fibrinogen. Intended for use with Clauss fibrinogen assay methodology.

Indications for Use

Indicated for use in clinical laboratories to prepare reference curves for the Clauss fibrinogen assay using Dade Behring Multifibrin U reagent.

Regulatory Classification

Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system 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

• Dade Behring Fibrinogen Standards (K925988)

Submission Summary (Full Text)

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Dade Behring Inc. Fibrinogen Calibrator Kit 510(k) Notification

K994341.

# MAR - 3 2000

### 510(k) Summary for Fibrinogen Calibrator Kit

- Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

| Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>Marburg/Germany |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.<br>Glasgow Site<br>P.O. Box 6101<br>Newark, Delaware 19714<br>Attn: Rebecca S. Ayash<br>Tel: [phone] |
| Preparation date: | December 22, 1999 |
| Device Name Classifications | |

#### 2. Device Name/ Classification:

Fibrinogen Calibrator Kit: Fibrinogen Calibrators

Class II (864.7340) Classification Number:

#### Identification of the Legally Marketed Device: 3.

Dade Behring Fibrinogen Standards (K925988)

#### 4. Device Description:

The Fibrinogen Calibrators are lyophilized calibrators prepared from pooled human plasma from selected, healthy donors, diluted with buffered solution or supplemented with purified fibrinogen and stabilized.

#### ર. Device Intended Use:

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.

#### Medical device to which equivalence is claimed and comparison information: 6.

There are a number of in vitro diagnostic products in commercial distribution, which are used for the establishment of reference curves. One such product is the Dade Behring Fibrinogen Standards (K925988). The Fibrinogen Calibrator Kit is substantially equivalent in intended use to the Fibrinogen Standards. The Fibrinogen Calibrator Kit, like the Fibrinogen Standards is intended to be used for the calibration of a fibrinogen assay

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Image /page/1/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 three wavy lines, which are meant to represent the human form.

## MAR - 3 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring Glasgow Site P.O. Box 6101 Newark, Delaware 19714

Re: K994341 Trade Name: Fibrinogen Calibrator Kit Regulatory Class: II Product Code: GFX Dated: February 18, 2000 Received: February 24, 2000

Dear Ms. Ayash:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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.

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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" (21CFR 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 Putman

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

Enclosure

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Dade Behring Inc. Fibrinogen Calibrator Kit 510(k) Notification

K994341

## Indications for Use Statement

Fibrinogen Calibrator Kit Device Name:

Indications for Use:

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.

ion Sign-Off Division of Clinical Laboratory Devi 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

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