FIBRINOGEN CALIBRATOR KIT

K072304 · Dade Behring, Inc. · GFX · Sep 19, 2007 · Hematology

Device Facts

• Record ID: K072304
• Device Name: FIBRINOGEN CALIBRATOR KIT
• Applicant: Dade Behring, Inc.
• Product Code: GFX · Hematology
• Decision Date: Sep 19, 2007
• 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 Multifibren™ U.

Device Story

Fibrinogen Calibrator Kit consists of six lyophilized calibrators derived from pooled human plasma; donors selected for health; plasma diluted with buffer or supplemented with purified fibrinogen; stabilized with Herpes Buffer. Supplied in siliconized vials to prevent coagulation contact activation. Used in clinical laboratory settings to establish reference curves for fibrinogen assays performed on automated coagulation analyzers (e.g., Dade Behring BCS, Sysmex CA-1500). Calibrator values assigned via Ratnoff and Menzie method and Kjeldahl method. Healthcare providers use these reference curves to quantify fibrinogen levels in patient samples, aiding in the assessment of coagulation status.

Clinical Evidence

No clinical data. Bench testing only. Evaluation of the new value assignment procedure involved testing three lots of the calibrator kit with two lots of Multifibren™ U reagent on Dade Behring BCS and Sysmex® CA-1500 analyzers. Results demonstrated that patient samples and quality control materials recovered fibrinogen values within expected ranges.

Technological Characteristics

Lyophilized pooled human plasma; stabilized with Herpes Buffer (12g/L); supplied in siliconized vials. Quantitative calibrator for fibrinogen assay. No specific software or electronic connectivity; used as a reagent component in coagulation analyzers.

Indications for Use

Indicated for use in preparing reference curves for the quantitative assay of fibrinogen via the Clauss method using Dade Behring Multifibren™ 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

• Fibrinogen Calibrator Kit (K994341)

Submission Summary (Full Text)

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K072304

# 510(k) Summary Fibrinogen Calibrator Kit

### 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

| Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>35041 Marburg, Germany | SEP 1 9 2007 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Information: | Dade Behring Inc.<br>Glasgow Site<br>Bldg. 500, M.S. 514<br>P.O. Box 6101<br>Newark, Delaware 19714-6101<br>Attn: Radames Riesgo<br>Tel: [phone] | |
| Preparation date: | August 16, 2007 | |

#### 2. Device Name/ Classification:

Fibrinogen Calibrator Kit / Fibrinogen determination system, Class II (864.7340)

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

Fibrinogen Calibrator Kit (K994341)

#### 4. Device Description:

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

#### 5. 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 Multifibren™ U.

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

The modified Fibrinogen Calibrator Kit is substantially equivalent in intended use and performance to the Fibrinogen Calibrator Kit (K994341) currently marketed. Both devices are intended for use as calibrators for fibrinogen determination using the Dade Behring Multifibren™ U 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Radames Riesgo Regulatory Affairs & Compliance Manager Dade Behring, Inc. P.O. Box 6101 Building 500 MS 514 Newark, Delaware 19714

SEP 1 9 2007

Re: k072304

Trade/Device Name: Fibrinogen Calibrator Kit Regulation Number: 21 CFR 864.7340 Regulation Name: Fibrinogen determination system Regulatory Class: Class II Product Code: GFX Dated: August 16, 2007 Received: August 17, 2007

Dear Mr. Riesgo:

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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Radames Riesgo

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 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical-Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 L. Becker, MD, PhD

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

## Indications for Use Statement

510(k) Number (if known):

K072304

Device Name: Fibrinogen Calibrator Kit

## 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 Multifibren™ U.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ughim Santude

Division Sign Of

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072304