ELECYS IGE ASSAY

K984326 · Boehringer Mannheim Corp. · JHR · Feb 8, 1999 · Immunology

Device Facts

• Record ID: K984326
• Device Name: ELECYS IGE ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: JHR · Immunology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.

Device Story

Elecsys IgE Test is an in vitro diagnostic immunoassay for quantitative IgE measurement in human serum/plasma. Operates on Boehringer Mannheim Elecsys 1010/2010 analyzers. Principle: sandwich heterogeneous immunological complex formation. Process: biotinylated monoclonal antibodies and ruthenium-labeled antibodies bind sample IgE; streptavidin-coated microparticles capture complex; magnetic capture on electrode; voltage application induces chemiluminescent emission measured by photomultiplier. Used in clinical laboratories by trained personnel. Output: quantitative IgE concentration. Clinical utility: aids diagnosis of allergic diseases. Benefits: liquid ready-to-use reagent, improved detection limits, and wider measuring range compared to photometric predicate.

Clinical Evidence

Bench testing only. Method comparison study (N=188) against predicate showed high correlation (r=1.0, Passing/Bablok y = -0.53 + 0.97x). Precision: Within-run CV 2.1-3.6%, Total CV 1.9-4.2%. Measuring range 0.10-4000 IU/mL. Specificity: no cross-reactivity with IgG, IgA, IgM. Interference testing performed for bilirubin, hemoglobin, lipemia, and biotin.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Sandwich principle using biotinylated monoclonal antibodies and ruthenium-labeled antibodies. Streptavidin-coated microparticles. Liquid, ready-to-use reagent. Analyzers: Elecsys 1010 and 2010. Measuring range: 0.10-4000 IU/mL.

Indications for Use

Indicated for in vitro quantitative determination of IgE in human serum and plasma as an aid in the diagnosis of allergic diseases.

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

• Boehringer Mannheim Enzymun-Test® IgE

Submission Summary (Full Text)

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.

510(k) Summary

·

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter<br>name, address,<br>contact | Roche Diagnostics, doing business in the US as Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>[phone] | | |
| | Contact person: Priscilla A. Hamill | | |
| | Date prepared: December 2, 1998 | | |
| Device name | Proprietary name: Elecsys® IgE Test | | |
| | Common name: IgE | | |
| | Classification name: Immunoglobulins A, G, M, D, and E immunological<br>test system | | |
| Predicate<br>device | We claim substantial equivalence to the Boehringer Mannheim Enzymun-<br>Test® IgE. | | |
| Device<br>description | The Elecsys® IgE test is based on the sandwich principle of heterogeneous<br>immunological complex formation. | | |
| | First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled<br>antibodies (R2), both specific for IgE, bind IgE present in the sample forming<br>a sandwich complex<br>Second Step: Microparticles coated with streptavidin (M) bind the biotin<br>portion of the complex and are captured magnetically onto the surface of the<br>electrode. Application of a voltage to the electrode induces chemiluminescent<br>emission, which is measured by a photomultiplier. | | |

02/04/99

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# 510(k) Summary, Continued

#### Intended use

For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

### Comparison to the predicate device

Similarities: The following table compares Boehringer Mannheim ® IgE Test with the predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5. Labeling for the predicate device is provided in Attachment 6.

| Feature | Elecsys® IgE Test | Enzymun-<br>Test® IgE. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Intended use | For the quantitative determination of IgE in human serum and plasma on the Elecsys 1010 and 2010 immunoassay analyzers. | For the quantitative determination of IgE in human serum and plasma on automated immunoassay analyzers |
| Indications for use | An aid in the diagnosis of allergic diseases | An aid in the diagnosis of allergic diseases |
| Sample type | Human serum, plasma | Human serum, plasma |
| Assay reaction principle | Sandwich principle, Heterogeneous immunological complex formation | Sandwich principle, Heterogeneous immunological complex formation, ELISA |
| Standardized against | WHO Standard | WHO Standard |

Continued on next page

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# 510(k) Summary, Continued

Comparison to the predicate device (cont.)

Differences: The following differences between Elecsys® IgE Test and the predicate device are not significant for purposes of determining substantial equivalence.

| Feature | Elecsys® IgE Test | Enzymun-Test® IgE. |
|----------------------|------------------------------------------------------------|-------------------------------------------------------------------|
| Measurement approach | Electrochemiluminescence | Photometric |
| Instrument required | Boehringer Mannheim Elecsys automated immunoassay analyzer | Boehringer Mannheim ES 300/300 AL automated immunoassay analyzers |
| Reagent Formulation | Liquid; ready to use | Lyophilized; reconstitution required |

Performance characteristics: The performance of the Elecsys® IgE Test is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test® IgE.

| Feature | Elecsys® IgE Test | Enzymun-Test® IgE. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within-Run %CV<br>3.6% at 5.18 IU/mL<br>2.1% at 105 IU/mL<br>2.8% at 197 IU/mL<br>3.2% at 398 IU/mL<br>2.4% at 1010 IU/mL<br><br>Total %CV<br>4.2% at 5.18 IU/mL<br>1.9% at 105 IU/mL<br>3.9% at 197 IU/mL<br>3.9% at 398 IU/mL<br>3.1% at 1010 IU/mL | Within-Run %CV<br>2.1% at 102.7 IU/mL<br>2.1% at 244.1 IU/mL<br>2.8% at 375.4 IU/mL<br><br>Total %CV<br>3.4% at 102.7 IU/mL<br>3.4% at 244.1 IU/mL<br>3.6% at 375.4 IU/mL |
| Lower<br>Detection<br>Limit | 0.10 IU/mL | 1.44 IU/mL |
| Measuring<br>Range | 0.10-4000 IU/ml | 1.44-500 IU/ml |

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# 510(k) Summary, Continued

Comparison to the predicate device (cont.)

Performance characteristics: continued

| Feature | Elecsys® IgE Test | Enzymun-Test® IgE. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Specificity | No cross-reactivity with the<br>immunoglobulins G, A and M was<br>detected. | No cross-reactions with IgG,<br>IgA and IgM was detected. |
| Method<br>comparison | Elecsys IgE vs Enzymun-Test IgE<br><br>Passing/Bablok<br>y = -0.53 + 0.97x<br>r = 1.0<br>SD (md68) = 2.42<br>N = 188<br><br>Linear regression<br>y = -1.85 + 1.01x<br>r = 1.0<br>Sy.x = 5.86<br>N = 188 | |
| Interfering<br>substances: | No interference at: | No interference at: |
| Bilirubin<br>Hemoglobin<br>Lipemia<br>Biotin | <37 mg/dL<br><1.1 g/dL<br><2200 mg/dL<br><100 ng/mL | <64.5 mg/dL<br><1 g/dL<br><1250 mg/dL<br><100 ng/mL |

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## 8 1999 FEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: K984326 Trade Name: Elecsys IgE Test Regulatory Class: II Product Code: JHR Dated: December 2, 1998 Received: December 3, 1998

## Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Elecsys® IgE Test

Indications for Use: For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence inmunoassay "ECLIA" is intended for use on the Bochringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

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

Rita E. Maisir

ision of Clinical Laboras

### (PLEASE. DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) .............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional format 1-2-96)

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