N LATEX IGM

K032014 · Dade Behring, Inc. · CFN · Aug 7, 2003 · Immunology

Device Facts

• Record ID: K032014
• Device Name: N LATEX IGM
• Applicant: Dade Behring, Inc.
• Product Code: CFN · Immunology
• Decision Date: Aug 7, 2003
• 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 IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient’s immune system.

Device Story

N Latex IgM is an in vitro diagnostic reagent kit used with BN™ Systems for quantitative IgM measurement in human CSF and serum. Principle of operation: particle-enhanced immunonephelometry. Polystyrene latex particles coated with anti-human IgM antibodies agglutinate upon contact with IgM in patient samples; agglutination causes light scattering of a beam passed through the sample. Scattered light intensity is proportional to IgM concentration. Results are calculated by comparing sample light scattering against a standard of known concentration. Used in clinical laboratory settings by trained personnel. Output assists clinicians in evaluating patient immune system status.

Clinical Evidence

Bench testing only. Method comparison studies were performed comparing N Latex IgM to the predicate device. Correlation data provided for CSF (n=24, slope 1.04, r=0.995), serum (n=50, slope 0.91, r=0.979), and CSF/serum ratio (n=24, slope 1.03, r=0.989).

Technological Characteristics

Reagents consist of polystyrene latex particles coated with antibodies specific to human IgM. Operates via particle-enhanced immunonephelometry on BN™ Systems. Measures light scattering intensity proportional to protein concentration. In vitro diagnostic use.

Indications for Use

Indicated for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and paired CSF/serum samples to aid in the evaluation of the patient’s immune system.

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

• Beckman Coulter IMMAGE® Immunochemistry System Low Concentration immunoglobulin M (IGMLC) assay (K993547)

Submission Summary (Full Text)

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ade Behring Inc 510(k) Notification

AUG - 7 2003

# 510(k) Summary for N Latex 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: _______________________________________________________________________________________________________________________________________________

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

Contact Information:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

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

Preparation date:

June 26, 2003

- 2. Device Name/ Classification:

| N Latex IgM: | Immunologlobulin A, G, D and E immunological test |
|---------------|---------------------------------------------------|
| | system, Class II (866.5510) |
| Product Code: | 81CFN |

- 3. Identification of the Legally Marketed Device: Beckman Coulter IMMAGE® Immunochemistry System Low Concentration immunoglobulin M (IGMLC) assay (K993547)
### 4. Device Description:

Polystyrene latex particles coated with antibodies specific to human IgM are agglutinated when mixed with samples containing human IgM. These aggregates 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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Dade Behring Inc. N Latex IgM 510(k) Notification

#### 5. Device Intended Use:

In vitro diagnostic reagents for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.

- Medical device to which equivalence is claimed and comparison information: 6. There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination of IgM in human serum or CSF. One such product is the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Assay (K993547). The N Latex IgM is substantially equivalent in intended use and results obtained to the IMMAGE® IGMLC assay.
#### 7. Device Performance Characteristics:

### Correlation:

| Assay | Sample<br>Type | (n=) | Slope | Intercept | Correlation<br>Coefficient |
|-------------|-----------------|------|-------|-----------|----------------------------|
| N Latex IgM | CSF | 24 | 1.04 | -0.02 | 0.995 |
| N Latex IgM | Serum | 50 | 0.91 | +0.02 | 0.979 |
| N Latex IgM | CSF/Serum Ratio | 24 | 1.03 | -0.01 | 0.989 |

### Method Comparison Studies

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Re:

AUG - 7 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Manager. Regulatory Affairs and Compliance Dade Behring. Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

k032014 Trade/Device Name: N Latex IgM Regulation Number: 21 CFR & 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test Regulatory Class: II Product Code: CFN Dated: June 26, 2003 Received: June 30, 2003

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. Iisting 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 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.

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Page 2 –

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. N Latex IqM 510(k) Notification

# Indications Statement

【,】

Device Name: N Latex IgM

## Indications for Use:

N Latex IgM is an in vitro diagnostic test for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:left;">✓</div> |
|--------------------------------------------------|---------------------------------------|
| Over-The-Counter-Use<br>(Optional Format 1-2-96) | |

*J.P. Reeves for S. Bautista*
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety510(k).