N ANTISERA TO HUMAN TRANSFERRIN

K053075 · Dade Behring, Inc. · DDG · Mar 16, 2006 · Immunology

Device Facts

• Record ID: K053075
• Device Name: N ANTISERA TO HUMAN TRANSFERRIN
• Applicant: Dade Behring, Inc.
• Product Code: DDG · Immunology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BN™ Systems.

Device Story

N Antisera to Human Transferrin is an in vitro diagnostic reagent kit used on BN™ Systems. It detects transferrin in human serum, plasma, or urine samples. Principle of operation: immunonephelometry; proteins in sample form immune complexes with specific antibodies; complexes scatter light beam; scattered light intensity is proportional to protein concentration. Result is determined by comparing intensity against a standard of known concentration. Used in clinical laboratory settings by trained personnel. Output provides quantitative transferrin levels to assist clinicians in diagnosing malnutrition, inflammation, infection, and anemia.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data including matrix comparison studies and interference testing. Matrix comparison (N=40-99 per group) showed high correlation (R² 0.9851-0.9936) between serum and plasma samples. Interference testing confirmed no significant interference from bilirubin, hemoglobin, triglycerides, or heparin anticoagulants.

Technological Characteristics

Quantitative immunonephelometry assay. Reagents: polyclonal rabbit anti-human transferrin antiserum. Instrumentation: BN™ Systems (BNII, BN 100, BN Prospec). Detection principle: light scattering intensity proportional to protein concentration. Sample matrices: serum, heparinized plasma, EDTA plasma, urine.

Indications for Use

Indicated for quantitative determination of transferrin in human serum, heparinized/EDTA plasma, and urine to aid in diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia).

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• N Antisera to Human Transferrin (k972840)

Submission Summary (Full Text)

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## 510(k) Summary for N Antisera to Human Transferrin

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number K053075. The number is written in a handwritten style, and there is an underline beneath it. The text is likely part of a document or form related to medical device approval.

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

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]

Preparation date:

February 17, 2006

- 2. Device Name/ Classification: N Antisera to Human Transferrin Class: Transferrin Immunological Test System, Class II, 21 CFR 866.5880 Panel: Immunology Product Code: DDG
### 3. Identification of the Legally Marketed Device:

N Antisera to Human Transferrin– K972840

#### 4. Device Description:

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

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#### 5. Device Intended Use:

In vitro diagnostic reagents for the quantitative determination of transferrin in human m viro diagnostic reagents for the qualifical as transferrin in human urine by means of immunonephelometry on the BN™ Systems.

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

The modified N Antisera to Human Transferrin assay is substantially equivalent to the N The modified N Antional terrin currently marketed (K972840). The modified N Antisera to / Introura to Human Transferrin assay, like the current N Antisera to Human Transferrin assay, is intended for the quantitative determination of transferrin by means of immunonephelometry on the BN™ Systems.

### Device Performance Characteristics: 7.

To demonstrate equivalence in measurement between serum and heparinized or EDTA plasma, method comparisons were performed. The studies demonstrate equivalent performance with correlation coefficients between 0.96 and 0.98

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 6 2006

Dade Behring, Inc. c/o Ms. Kathleen A Dray-Lyons Glasgow Site P.O. Box 6101 Newark, DE 19714

Re: k053075

Trade/Device Name: N Antisera to Human Transferrin Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG Dated: October 28, 2005 Received: November 1, 2005

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becally be (the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stared in also introduction of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nat (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 may of 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w you'ls ought inding of substantial equivalence of your device to a legally prematics notification: "The PDF Intentig sification 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 11 you desire spoonly and [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other Wilsonation of 10.0.2017 responsibilities under the Act from the Division of Small general international on your copying 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 H. Beckerf

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

Enclosure

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# Indications Statement

Device Name:

N Antisera to Human Transferrin Assay

## Indications for Use:

In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BN™ Systems. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Prescription Use × (Per 21 CFR 801 Subpart D) 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)

Maria Chan

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Alice of In Vitro Diagnostic Device " whichon and Safety

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