N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

K053073 · Dade Behring, Inc. · DEB · Mar 28, 2006 · Immunology

Device Facts

• Record ID: K053073
• Device Name: N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
• Applicant: Dade Behring, Inc.
• Product Code: DEB · Immunology
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5620
• Device Class: Class 2

Intended Use

In vitro diagnostic reagents for the quantitative determination of α2-macroglobulin in human serum and heparinized plasma by means of immunonephelometry on the BN™ systems. For prescription use only.

Device Story

In vitro diagnostic reagent kit for quantitative measurement of a2-macroglobulin in human serum and heparinized plasma. Operates via immunonephelometry on BN™ Systems; specific antibodies form immune complexes with target proteins in patient samples. These complexes scatter light; intensity of scattered light is proportional to protein concentration. Results are calculated by comparing sample light scatter against a standard of known concentration. Used in clinical laboratory settings by trained personnel. Output aids clinicians in diagnosing blood clotting or clot lysis disorders.

Clinical Evidence

Bench testing only. Method comparison study performed to validate the use of heparinized plasma alongside serum. Results demonstrated equivalent performance with a correlation coefficient of 0.98.

Technological Characteristics

Quantitative immunonephelometry assay. Reagent: Rabbit anti-human α2-macroglobulin (polyclonal). Instrumentation: BN™ Systems (BNII, BN 100, BN Prospec). Sensing principle: Light scattering intensity proportional to antigen-antibody complex concentration. Sample matrices: Serum and heparinized plasma.

Indications for Use

Indicated for the quantitative determination of α2-macroglobulin in human serum and heparinized plasma to aid in the diagnosis of blood clotting or clot lysis disorders.

Regulatory Classification

Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Predicate Devices

• N Antisera to Human a2-Macroglobulin (K860894)

Submission Summary (Full Text)

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MAR 2 8 2006

## 510(k) Summary for N Antisera to Human α2-Macroglobulin

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.

The assigned 510(k) number is:

### 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:

October 28, 2005

- 2. Device Name/ Classification: N Antisera to Human a2-Macroglobulin Class: 02-Macroglobulin Immunological Test System, Class II, 21 CFR 866.5620 Panel: Immunology Product Code: DEB
#### 3. Identification of the Legally Marketed Device:

N Antisera to Human a2-Macroglobulin- K860894

#### 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 g ~ macroglobulin in human serum and heparinized plasma by means of immunonephelometry on the BN™ Systems.

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

The modified N Antisera to Human മ₂-Macroglobulin assay is substantially equivalent to the N Antisera to Human a - Macroglobulin currently marketed (K860894). The modified N Antisera to Human a2-Macroglobulin assay, like the current N Antisera to Human α2-Macroglobulin assay, is intended for the quantitative determination of a2-macroglobulin by means of immunonephelometry on the BN™ Systems.

#### 7. Device Performance Characteristics:

To demonstrate equivalence in measurement between serum and heparinized plasma, a method comparison was performed. This study demonstrates equivalent performance with a correlation coefficient of 0.98

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 8 2006

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

Re: k053073

Trade/Device Name: N Antisera to Human a2-Macroglobulin Assay Regulation Number: 21 CFR 866.5620 Regulation Name: Alpha-2-Macroglobulin Immunological Test System Regulatory Class: Class II Product Code: DEB 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 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 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.

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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,

Zaber 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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Dade Behring Inc. N Antisera to Human α2-Macroglobulin Assay 510(k) Notification - Modification

# Indications Statement

K053073

Device Name:

N Antisera to Human a2-Macroglobulin Assay

Indications for Use:

In vitro diagnostic reagents for the quantitative determination of a2-macroglobulin in human serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of a>-macroglobulin may aid in the diagnosis of blood clotting or clot lysis disorders.

Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)

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

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