IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

K024210 · Beckman Coulter, Inc. · DGC · Feb 24, 2003 · Immunology

Device Facts

• Record ID: K024210
• Device Name: IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: DGC · Immunology
• Decision Date: Feb 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

Device Story

The IMMAGE Immunochemistry System Total IgE reagent is an in vitro diagnostic assay for quantitative measurement of total human IgE in serum or plasma. The system utilizes rate turbidimetry, where mouse monoclonal antibodies react with IgE in the patient sample to form immune complexes; the rate of complex formation is measured optically. The device is intended for use in clinical laboratory settings by trained personnel. Results are used by clinicians to assist in the diagnosis and management of atopic conditions and to evaluate potential atopic tendencies in infants. The system provides a wider measuring range (up to 30,000 IU/mL with dilution) compared to the predicate, facilitating the assessment of elevated IgE levels associated with allergic diseases, parasitic infections, and other clinical conditions.

Clinical Evidence

Bench testing only. Performance demonstrated via method comparison against the Access Total IgE predicate (n=125, slope 1.06, intercept 2.75, r=0.991). Imprecision studies (n=80 per level) showed within-run CVs of 5.1-5.8% and total imprecision CVs of 6.3-7.3% across three concentration levels.

Technological Characteristics

Liquid stable reagent; mouse monoclonal antibody; rate turbidimetry sensing principle; automated clinical chemistry analyzer platform.

Indications for Use

Indicated for quantitative determination of total human IgE in serum or plasma to aid in diagnosis and management of atopic diseases (asthma, hay fever, atopic dermatitis, urticaria) and to distinguish atopic from non-atopic individuals. Applicable to all ages, including infants (cord blood/infant levels predictive of future atopic tendencies).

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

• Access® Total IgE (K930984)

Submission Summary (Full Text)

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1024210
FEB 24 2003

### 510(k) Summary IMMAGE® Immunochemistry System Total Immunoglobulin E Reagent (IGE) Reagent and Calibrator

#### 1.0 Submitted By:

Annette Hellie Requlatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

December 19, 2002

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) Reagent IMMAGE® Immunochemistry System IGE Calibrator

#### 3.2 Classification Name

Immunoglobulins A, G, M, D, and E test system (21 CFR § 866.5510) Calibrator (21 CFR § 862.1150)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|----------------------------|-------------------|--------------------------|------------------|
| IMMAGE System<br>Total IGE | Access® Total IgE | Beckman<br>Coulter, Inc. | K930984 |

#### 5.0 Description:

Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

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#### 6.0 Intended Use:

Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry ..

# Clinical Significance:

IgE is a member of the immunoglobulin family of proteins that was first described in the 1960's. IgE. like all immunodlobulins, is produced by plasma cells in response to antigenic stimuli. IgE is unique however in certain structural aspects and the role it plays in allergic diseases.

Measurement of total serum IgE is often used as a tool in the diagnosis and management of atopic diseases such as asthma, hay fever, atopic dermatitis and urticaria. It has been used to distinguish atopic from non-atopic individuals presenting allergy-like symptoms. In addition, studies have also shown that increased levels of IgE in cord blood and infants may be predictive of future atopic tendencies.

Normal levels of circulating IgE are extremely low in comparison to other immunoqlobulins. Levels of IgE at birth are almost undetectable but increase in non-allergic adults. Elevated levels are commonly seen in cases of allergic diseases, parasitic infections, pulmonary aspergillosis, Wiskott-Aldrich Syndrome, and myeloma.

Serum IqE levels may vary as a result of diet, genetic background, geographical location and other factors. It is therefore recommended that total IqE measurements be used in conjunction with other clinical tests when establishing diagnoses.

#### 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| | Similarities | |
|----------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------|
| IMMAGE System<br>Total IGE | Intended Use | Same as Access Total IgE |
| | Liquid stable reagent | |
| | Antibody (mouse<br>monoclonal) | |
| | Differences | |
| IMMAGE System<br>Total IGE | Methodology | The IMMAGE uses rate nephelometry and<br>the Access uses chemiluminescent<br>immunoassay |
| | Measuring range | 0.25-3000 IU/mL for Access<br>5.0 - 500 IU/mL (initial dilution) up to<br>30,000 (extended dilution) for IMMAGE |

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#### Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

| Analyte | Slope | Intercept | r | n | Predicate Method |
|---------------------|-------|-----------|-------|-----|------------------|
| IMMAGE<br>Total IGE | 1.06 | 2.75 | 0.991 | 125 | Access Total IgE |

Method Comparison Study Results

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 16.5 | 0.97 | 5.8 | 80 |
| Level 2 | 145 | 7.4 | 5.1 | 80 |
| Level 3 | 383 | 19.9 | 5.2 | 80 |
| Total Imprecision | | | | |
| Level 1 | 16.5 | 1.11 | 6.7 | 80 |
| Level 2 | 145 | 9.1 | 6.3 | 80 |
| Level 3 | 383 | 28.1 | 7.3 | 80 |

## IMMAGE System IGE Estimated Imprecision

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

Ms. Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92822-8000

FEB 24 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

024210
Trade/Device Name: IM
Rea
Regulation Number: 21 C
Regulation Name: Immu
Regulatory Class: II

FEB 2 4 2003

Re: k024210

Trade/Device Name: IMMAGE® Immunochemistry System Total Immunoglobulin E Reagent (IGE) Reagent and Calibrator Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Test System Regulatory Class: II Product Code: DGC Dated: February 11, 2003 Received: February 12, 2003

Dear Ms. Hellie:

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 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 Butman

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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page ___ of _/

510(k) Number (if known): K02 42 /O

### Device Name: IMMAGE® Immunochemistry System Total Immunoglobulin E Reagent (IGE) Reagent and Calibrator

Indications for Use:

Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (per 21 CFR 801.109) | ✓ |
|---------------------------------------|---|
|---------------------------------------|---|

OR

| Over-the-Counter Use | |
|------------------------|--|
| Optional Format 1-2-96 | |

*J. P. Reave for J. Bautista*
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | 1C054210 |
|---------------|----------|
|---------------|----------|

Beckman Coulter, Inc., Section 510(k) Notification IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) IGE510K_Section1.doc, December 2002