N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)

K042735 · Dade Behring, Inc. · CFN · Feb 15, 2005 · Immunology

Device Facts

• Record ID: K042735
• Device Name: N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
• Applicant: Dade Behring, Inc.
• Product Code: CFN · Immunology
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, lgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems.

Device Story

In vitro diagnostic reagents for quantitative measurement of immunoglobulins (IgG, IgA, IgM) in human serum, plasma, and CSF. Operates via immunonephelometry on BN™ Systems; proteins in sample form immune complexes with specific antibodies; complexes scatter light; scattered light intensity proportional to protein concentration. Results compared against known standards. Used in clinical laboratory settings by trained personnel. Output provides quantitative protein levels to assist clinicians in diagnosing abnormal protein metabolism and immune resistance deficiencies.

Clinical Evidence

Bench testing only. Performance evaluated by comparing results across different sample matrices (heparinized plasma, EDTA plasma) against serum. Study included 49 heparinized and 20 EDTA samples. Results showed high correlation (r-values 0.920–1.003) and minimal bias, confirming substantial equivalence to the predicate.

Technological Characteristics

Immunonephelometric assay reagents. Principle: light scattering by immune complexes. Platform: BN™ Systems. Analyte detection: IgG, IgA, IgM. Sample types: serum, heparinized plasma, EDTA plasma, CSF (IgG only).

Indications for Use

Indicated for the quantitative determination of IgG, IgA, and IgM in human serum, heparinized plasma, and EDTA plasma, and IgG in human cerebrospinal fluid (CSF). Aids in the diagnosis of abnormal protein metabolism and immune deficiency states.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay (K860894)

Submission Summary (Full Text)

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# 510(k) Summary for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

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: _______________________________________________________________________________________________________________________________________________

### Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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: Kathieen Dray-Lyons Tel: [phone] Fax: [phone]

Preparation date:

September 30, 2004

- 2. Device Namel Classification: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay Class: Immunological Test System, Class II, 21 CFR 866.5510 Panel: Immunology Product Code: CFN
#### 3. Identification of the Legally Marketed Device:

N Antisera to Human Immunoglobulins (IgG, IgA and IgM) - K860894

#### Device Description: 4.

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 immunoglobulins (IgG, lgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems.

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

The modified N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay is substantially equivalent to the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) currently marketed (K860894). The modified N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay, like the current N Antisera to Human Immunoglobulins (IgG, lgA, and IgM) assay, is intended for the quantitative determination of immunoglobulins (IgG, IgA and IgM) by means of immunonephelometry on the BN™ Systems.

#### 7. Device Performance Characteristics:

| 11 3 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -<br>16 2012 2018 11:20 | Sprunt vorsusel<br>11 - 3 - 3 - 3 - 3 - 3 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | BECK BEACH | and the country of the country of the consideration of the successful and the subsequence of the subsequence of the subsequence of the sub- | a mailied and a more and the maint of the maile one | and accompany in |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------|
| lgG | Heparinized | 49 | 0.969 | 0.155 | 0.993 |
| | EDTA | 20 | 0.978 | -0.102 | 0.993 |
| laA | Heparinized | 49 | 1.003 | -0.031 | 0.998 |
| | EDTA | 20 | 0.947 | 0.014 | 0.998 |
| laM | Heparinized | 49 | 0.988 | 0.001 | 0.994 |
| | EDTA | 20 | 0.920 | 0.024 | 0.994 |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the right and has a stylized design.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 5 2005

Dade Behring, Inc. c/o Ms. Kathleen A Dray-Lyons Regulatory Affairs and Compliance Manager P.O. Box 6101 Newark, DE 19714

Re: k042735

k042 133
Trade/Device Name: N Antisera to Human Immunoglobulins (IgG, IgA and IgM) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test Systems Regulatory Class: Class II Product Code: CFN Dated: September 30, 2004 Received: October 1, 2004

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your boother to the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround to regard date of the Medical Device Amendments, or to devices that prior to May 26, 1770, the onadances with the provisions of the Federal Food, Drug, and Cosmetic have been recuire and acceraroval of a premarket approval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, matice the detrice, day of the manual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice to such additional controls. Existing major regulations affecting your device can be may be subject to sam adazine , 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 r reast of advisou that I be remination that your device complies with other requirements of the Act or that FDA mas made a decemination administered by other Federal agencies. You must comply with ally rederal statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, morading, sectice requirements as set forth in the quality labeling (21 CFR Part 807), good bart 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

comfor provisions (Sections 551 - 12 tresteting your device as described in your Section 510(k) I ins icter will anow you to objin maintaing of substantial equivalence of your device to legally

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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 If you desire specific advice for your ac not to rease note the regulation entitled, comaci the Office of Comphance at (210) at Cetion" (21CFR Part 807.97). You may obtain other MISolanding of reference to promaibilities under the Act from the Division of Small general international on your responsibilities at its toll-free number [phone] or [phone] or at its Internet address

[phone] of at its intornet audioss
http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert Beckh.

Robert L. Becker, Jr., M.D., PhØ 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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Antisera to Human Immunoglobulins (IgG, IgA and IgM) Assay 510(k) Notification - Modification

## Indications Statement

K042735

Device Name:

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay

Indications for Use:

In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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 Olan

Division Sign-Off

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042753

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