N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN

K053072 · Dade Behring, Inc. · DEM · Mar 28, 2006 · Immunology

Device Facts

• Record ID: K053072
• Device Name: N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
• Applicant: Dade Behring, Inc.
• Product Code: DEM · Immunology
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Intended Use

In vitro diagnostic reagents for the quantitative determination of a -antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BN™ Systems. The measurement of a-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a r-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.

Device Story

In vitro diagnostic reagent kit for quantitative measurement of alpha-1-antitrypsin in human serum, heparinized plasma, or EDTA plasma. Operates via immunonephelometry on BN™ Systems; proteins in sample form immune complexes with specific antibodies; complexes scatter light beam; scattered light intensity proportional to protein concentration; result determined by comparison against known standard. Used in clinical laboratory settings by trained personnel. Output aids clinicians in diagnosing liver cirrhosis and pulmonary emphysema associated with alpha-1-antitrypsin deficiency.

Clinical Evidence

Bench testing only. Method comparison studies performed to demonstrate equivalence between serum and heparinized or EDTA plasma. Results showed correlation coefficients between 0.97 and 0.99.

Technological Characteristics

Quantitative immunonephelometry reagent; polyclonal rabbit anti-human α1-antitrypsin antibody. Form factor: 2mL or 5mL vials. Instrumentation: BN II, BN 100, BN ProSpec® Nephelometers. Measurement range: 0.16–5.2 g/L. No specific material standards or software algorithm classes (e.g., ML) are described; the system relies on light scattering intensity proportional to immune complex formation.

Indications for Use

Indicated for the quantitative determination of α1-antitrypsin in human serum, heparinized and EDTA plasma to aid in the diagnosis of conditions including adult cirrhosis of the liver and pulmonary emphysema, in conjunction with other clinical and laboratory findings.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Predicate Devices

• N Antisera to Human a - Antitrypsin (K860894)

Submission Summary (Full Text)

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MAR 2 8 2006

## 510(k) Summary for N Antisera to Human αィ-Antitrypsin

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: K05

### 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 α-Antitrypsin Class: a4-Antitrypsin Immunological Test System, Class II, 21 CFR 866.5130 Panel: Immunology Product Code: DEM
#### 3. ldentification of the Legally Marketed Device:

N Antisera to Human a - Antitrypsin - K860894

#### 4. Device Description:

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes statter 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 a-antitrypsin in human serum, heparinized and EDTA plasma 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 a -- Antitrypsin assay is substantially equivalent to the N Antisera to Human a - Antitrypsin currently marketed (K860894). The modified N. Antisera to Human a - Antitrypsin assay, like the current N Antisera to Human a - Antitrypsin assay, is intended for the quantitative determination of a - antitrypsin by means of immunonephelometry on the BN™ Systems.

#### 7. Device Performance Characteristics:

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 0.97 and 0.99

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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 consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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: k053072

Trade/Device Name: N Antisera to Human al-Antitrypsin Assay Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1-Antitrypsin Immunological Test System Regulatory Class: Class II Product Code: DEM 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 (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 vour 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,

Robert A. Becker/

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

K053072

Device Name:

N Antisera to Human α - Antitrypsin Assay

## Indications for Use:

In vitro diagnostic reagents for the quantitative determination of a -antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BN™ Systems. The measurement of a-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a r-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.

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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Office of In Vitro Diagnostic Device Evaluation and Safety

053072