ELECSYS IGE II IMMUNOASSAY

K061970 · Roche Diagnostics · JHR · Aug 31, 2006 · Immunology

Device Facts

• Record ID: K061970
• Device Name: ELECSYS IGE II IMMUNOASSAY
• Applicant: Roche Diagnostics
• Product Code: JHR · Immunology
• Decision Date: Aug 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Device Story

Elecsys IgE II is a two-step sandwich immunoassay using streptavidin-coated microparticles and electrochemiluminescence detection. Input: human serum or plasma samples. Process: sample reacts with biotinylated monoclonal antibody and ruthenium-labeled monoclonal antibody; streptavidin microparticles capture complex; electrochemiluminescence signal generated upon voltage application. Output: quantitative IgE concentration calculated via instrument-specific calibration curve and master curve. Used in clinical laboratory settings on Roche Elecsys 2010 or MODULAR ANALYTICS E170 analyzers. Results assist clinicians in diagnosing allergic diseases.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by analytical performance data, including precision (intra-assay and total CVs) and interference testing (bilirubin, hemoglobin, triglycerides, biotin).

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles. Reagents include biotinylated monoclonal antibody and ruthenium-labeled monoclonal antibody. Standardized against 2nd IRP WHO Reference Standard 75/502. Measuring range 0.100–2500 IU/mL. Analyzers: Roche Elecsys 2010 and MODULAR ANALYTICS E170.

Indications for Use

Indicated for in vitro quantitative determination of total IgE in human serum and plasma to aid in the diagnosis of allergic diseases. For prescription use only.

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

• Elecsys IgE immunoassay (K984326, K961481/A003)

Submission Summary (Full Text)

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# K061970

AUG 3 1 2006

### 510(k) Summary - Elecsys IgE II Immunoassay

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Kay A. Taylor<br>Date prepared: July 11, 2006 |
| Device Name | Proprietary name: Elecsys IgE II immunoassay<br>Common name: IgE test<br>Classification name: radioimmunoassay, immunoglobulins (d, e) |
| Device description | The Elecsys IgE II immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. |
| Intended Use / Indications for Use | Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. |
| Substantial equivalence | The Elecsys IgE II immunoassay is substantially equivalent to another device legally marketed in the United States. Elecsys IgE II (modified) assay is equivalent to the Elecsys IgE immunoassay (K984326, K961481/A003). Both products are intended for use in the quantitative determination of IgE in serum and plasma. |
| Device Comparison | The table below compares the device features of the Elecsys IgE II immunoassay (modified) and original (K984326, K961481/A003). |

Confidential

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## 510(k) Summary – Elecsys IgE II Immunoassay, continued

| Topic | Elecsys IgE (K984326,<br>K961481/A003) | Elecsys IgE II (Modified Device) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Immunoassay for the in vitro<br>quantitative determination of<br>immunoglobulin E in human serum<br>and plasma. Determination of total<br>IgE is useful as an aid in the diagnosis<br>of allergic diseases. | Same |
| Analyzers | Roche Elecsys 1010/2010 and<br>MODULAR ANALYTICS E170<br>(Elecsys module) immunoassay<br>analyzers. | Roche Elecsys 2010 and MODULAR<br>ANALYTICS E170 (Elecsys module)<br>immunoassay analyzers. |
| Traceability | Assay standardized against the 2nd IRP<br>WHO Reference Standard 75/502 | Same |
| Assay Protocol | Sandwich | Same |
| Sample Type | Serum and plasma | Same |
| Calibrator,<br>Calibration<br>Verification &<br>Controls | IgE CalSet<br>IgE CalCheck<br>PreciControl Universal | Same |
| Measuring<br>Range | 0.10-2500 IU/ml | Same |
| Analytical<br>Sensitivity | 0.10 IU/ml | Same |
| Functional<br>Sensitivity | 0.50 IU/ml | Same |
| Composition | R1: 2.4 mg/L AB-Bi, buffer,<br>preservative<br>R2: 4.8 mg/L AB-Ru, buffer,<br>preservative<br>M: 0.72 mg/ml streptavidin-coated<br>microparticles, preservative | R1: 2.5 mg/L (mono-Bi)AB-Bi,<br>buffer, preservative<br>R2: 5.5 mg/L AB-Ru, buffer,<br>preservative<br>M: 0.72 mg/ml streptavidin-coated<br>microparticles, preservative |
| Dilution<br>Recommendation | Concentration of diluted samples must<br>be > 60 IU/mL | Concentration of diluted samples must<br>be > 125 IU/mL |
| Interferences | No affect up to,<br>bilirubin < 37 mg/dl<br>hemoglobin < 1.1 g/dl<br>triglycerides < 2200 mg/dl<br>biotin < 100 ng/ml | No affect up to,<br>Bilirubin - Same<br>hemoglobin < 0.1 g/dl<br>triglycerides - Same<br>biotin - Same |

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## 510(k) Summary – Elecsys IgE II Immunoassay, continued

| Topic | Elecsys IgE (K984326,<br>K961481/A003) | | Elecsys IgE II (Modified Device) | |
|-----------|----------------------------------------|------------|----------------------------------|------------|
| Precision | Elecsys 1010 / 2010: | | Elecsys 2010: | |
| | Intra-assay | | Intra-assay: | |
| | HS1 3.6% CV @ | 5.18 IU/mL | HS1 4.1% CV @ | 32.7 IU/mL |
| | HS2 3.2% CV @ | 398 IU/mL | HS2 2.4% CV @ | 265 IU/mL |
| | HS3 2.4% CV @ | 1010 IU/mL | HS3 2.6% CV @ | 1295 IU/mL |
| | Total: | | Total: | |
| | HS1 4.2% CV @ | 5.18 IU/mL | HS1 5.1% CV @ | 32.7 IU/mL |
| | HS2 3.9% CV @ | 398 IU/mL | HS2 3.8% CV @ | 265 IU/mL |
| | HS3 3.1% CV @ | 1010 IU/mL | HS3 3.9% CV @ | 1295 IU/mL |
| | E170: | | E170: | |
| | Intra-assay | | Intra-assay: | |
| | HS1 2.3% CV @ | 3.36 IU/mL | HS1 1.4% CV @ | 4.4 IU/mL |
| | HS2 2.2% CV @ | 457 IU/mL | HS2 0.7% CV @ | 261 IU/mL |
| | HS3 2.6% CV @ | 1128 IU/mL | HS3 1.0% CV @ | 1018 IU/mL |
| | Total: | | Total: | |
| | HS1 4.3% CV @ | 3.31 IU/mL | HS1 2.7% CV @ | 30.2 IU/mL |
| | HS2 3.8% CV @ | 443 IU/mL | HS2 2.8% CV @ | 245 IU/mL |
| | HS3 6.5% CV @ | 1215 IU/mL | HS3 3.4% CV @ | 1207 IU/mL |

#### Confidential

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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 features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Affairs Principal US Regulatory Affairs Roche Diagnostics, Inc. 9115 Hague Road P.O. Box 50416 Indianapolis, Indiana 46250-0416

AUG 3 1 2006

k061970 Re:

Trade/Device Name: Elecsys IgE II Immunoassay Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test System Regulatory Class: II Product Code: JHR Dated: August 22, 2006 Received: August 23, 2006

Dear Ms. Taylor:

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 for about 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 I hat 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 Or re rate overy, societing (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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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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

19061970

Device Name: Elecsys IgE II Immunoassay

Indications For Use:

Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma.

Determination of total IgE is useful as an aid in the diagnosis of allergic diseases.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Peter R. Roper

Division Sign-Off

ce of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061970

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Confidential