N LATEX IGA

K024038 · Dade Behring, Inc. · CZP · Feb 13, 2003 · Immunology

Device Facts

• Record ID: K024038
• Device Name: N LATEX IGA
• Applicant: Dade Behring, Inc.
• Product Code: CZP · Immunology
• Decision Date: Feb 13, 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 IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA aids in the evaluation of the patient's immune system.

Device Story

N Latex IgA is an in vitro diagnostic reagent kit used with BN™ Systems for quantitative IgA measurement. Input: human CSF or serum samples. Principle: particle-enhanced immunonephelometry; polystyrene latex particles coated with anti-human IgA antibodies agglutinate in the presence of IgA; intensity of scattered light is measured. Output: IgA concentration determined by comparing light scatter intensity against known standard dilutions. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in evaluating patient immune system status.

Clinical Evidence

Bench testing only. Performance evaluated via correlation studies comparing N Latex IgA to predicate methods across 50 CSF samples, 50 serum samples, and 50 serum/CSF ratio samples. Results showed high correlation coefficients: 0.991 (CSF), 0.992 (Serum), and 0.988 (Serum/CSF Ratio).

Technological Characteristics

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

Indications for Use

Indicated for the quantitative determination of IgA 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 A (IGALC) assay (K993549)

Submission Summary (Full Text)

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FEB 1 3 2003

## 510(k) Summary for N Latex IgA

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: _ K 0 2 4 0 3 8

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

Manufacturer:

Marburg/Germany

Contact Information:

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

Dade Behring Marburg GmbH

Emil-von-Behring Str. 76

Preparation date:

December 4, 2002

#### Device Name/ Classification: 2.

| N Latex IgA: | Immunoglobulin A, G, M, D and E immunological test |
|---------------|----------------------------------------------------|
| | system, Class II (866.5510) |
| Product Code: | 81 CZP |

#### Identification of the Legally Marketed Device: 3.

Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) assay (K993549)

#### 4. Device Description:

Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

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#### 5. Device Intended Use:

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

- 6. Medical device to which equivalence is claimed and comparison information: There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination IgA in human serum or CSF. One such product is the Beckman Coulter IMMAGE® Immunochemistry System IGALC assay (K993549). The N Latex igA is substantially equivalent in intended use and results obtained to the IMMAGE® IGALC assay. The N Latex IgA, like IMMAGE® IGALC assay is intended to be used for the quantitative determination of IgA in human serum or CSF.
#### 7. Device Performance Characteristics:

| Assay | Sample Type | (n=) | Slope | Intercept | Correlation Coefficient |
|-------------|-----------------|------|-------|-----------|-------------------------|
| N Latex IgA | CSF | 50 | 1.008 | -0.324 | 0.991 |
| | Serum | 50 | 1.123 | -0.067 | 0.992 |
| | Serum/CSF Ratio | 50 | 0.910 | -0.146 | 0.988 |

### Correlation:

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 3 2003

Re: k024038

Trade/Device Name: N Latex IgA Regulation Number: 21 CFR & 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test Regulatory Class: II Product Code: CZP Dated: January 29, 2003 Received: January 31, 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 (OS) 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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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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# K024038 Indications Statement

Device Name: N Latex IgA

## Indications for Use:

In vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA 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)

| (Division Sign-Off) | <i>J PReeves for J. Bautista</i> |
|-----------------------------------------|----------------------------------|
| Division of Clinical Laboratory Devices | |

| 510(k) Number | K024038 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
|------------------------------------------|--------------------------------------------------|
|------------------------------------------|--------------------------------------------------|

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