ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01

K062583 · Phadia US, Inc. · MVM · Dec 26, 2006 · Immunology

Device Facts

• Record ID: K062583
• Device Name: ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
• Applicant: Phadia US, Inc.
• Product Code: MVM · Immunology
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

EliA™ Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA™ Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with Celiac disease. EliA™ Celikey IgG uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

Device Story

EliA Celikey IgG is an in vitro diagnostic immunoassay for detecting IgG antibodies to tissue transglutaminase (tTG). The device uses human recombinant tTG coated on EliA wells as the solid phase. Patient serum or plasma is added; if anti-tTG IgG is present, it binds to the antigen. After washing, a mouse anti-human IgG beta-galactosidase conjugate is added, followed by a development solution. The resulting fluorescence is measured by the ImmunoCAP 100 or ImmunoCAP 250 automated analyzers. The system compares sample fluorescence to a stored calibration curve derived from WHO-standardized IgG calibrators. The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing celiac disease by quantifying the presence of specific IgG antibodies.

Clinical Evidence

Clinical performance evaluated using 93 patients with Celiac disease and 101 non-CD disease controls. Clinical sensitivity was 43.0% (95% CI: 32.8-53.7%) and clinical specificity was 96.0% (95% CI: 90.2-98.9%). Method comparison with the predicate (n=318) showed 92.4% positive agreement and 97.3% negative agreement. Analytical studies confirmed no interference from bilirubin, hemoglobin, chyle, or rheumatoid factor.

Technological Characteristics

Fluoroenzyme immunoassay; microwell solid phase coated with recombinant human tTG. Detection via β-galactosidase-labeled anti-human IgG conjugate and 4-methylumbelliferyl-β-D galactoside substrate. Automated processing on ImmunoCAP 100/250 platforms. Modular reagent system. Fluorescence signal measurement. Calibrators traceable to WHO IRP 67/86.

Indications for Use

Indicated for the in vitro semi-quantitative measurement of IgG antibodies to tissue transglutaminase (tTG) in human serum and plasma to aid in the clinical diagnosis of celiac disease.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• Celikey® Tissue Transglutaminase IgG Antibody (k041173)

Submission Summary (Full Text)

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K062583

DEC 2 6 2006

#### 9. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

| Assigned 510(k) Number: | k062583 | | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----------|
| Date of Summary Preparation: | Wednesday, December 13, 2006 | | |
| Manufacturer: | Phadia AB<br>Rapsgatan 7<br>SE-751 37 Uppsala, Sweden | | |
| 510 (k) Contact Person: | Martin Mann<br>Regulatory Affairs Manager<br>Phadia US Inc.<br>4169 Commercial Avenue<br>Portage, Mi 49002, USA<br>+1 (-269-492) -1957 (Phone)<br>+1 (-269-492) -7541 (Fax)<br>[e-mail] | | |
| Device Name: | EliA™ Celikey IgG | | |
| Common Name: | Tissue transglutaminase autoantibodies<br>immunological test system, Antigen | | |
| Classification | | | |
| Product Name | Product Code | Class | CFR |
| EliA™ Celikey IgG | MVM | II | 866.5660 |
| Substantial Equivalence to | | | |

Celikey IgG Tissue Transglutaminase (human, recombinant) IgG Antibody Assay 510(k) number: K041173

CONFIDENTIAL AND PROPRIETARY

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## Intended Use Statement of the New Device

EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as the antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease. EliA Celikey IgG uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

Special condition for use statement The device is for prescription use only.

#### Special instrument requirements

ImmunoCAP100/ImmunoCAP250 are fully automated immunoassay analyzers, that include software for evaluation of test results.

## General Description of the New Device

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

### Test Principle of the New Device

The EliA Celikey IgG Wells are coated with human recombinant tTG. If present in the patient's specimen, antibodies to tTG bind to their specific antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgG antibodies (EliA IgG Conjugate) are added to form an antibody-conjugate complex. After incubation, non-bound conjugate is washed away and the bound complex is incubated with a Development Solution. After stopping the reaction, the fluorescence in the reaction mixture is measured. The higher the response value, the more specific IgG is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.

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## Device Comparison

The new and the predicate device both represent non-competitive solid phase EIAs. Both IVDs are used as an aid in the diagnosis of Coeliac Disease.

### Laboratory equivalence

The comparability of predicate device and new device is supported by a data set including

- · results obtained within a comparison study between new and predicate device
- results obtained for clinically defined sera
- · results obtained for samples from apparently healthy subjects (normal population).

In summary, all available data support that the new device is substantially equivalent to the predicate device.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 26 2006

Phadia US, Inc. c/o Mr. Martin R. Mann Regulatory Affairs Manager 4169 Commercial Ave. Portage, MI 49002

Re: k062583 Trade/Device Name: EliA™ Celikey IgG Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Antibodies Immunological Test System Regulatory Class: Class II Product Code: MVM Dated: August 31, 2006 Received: September 6, 2006

Dear Mr. Mann:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

Robert L. Beeker

Robert L. Becker, Jr., M.D., Ph.D. Director

Division of Immunology and Hematology Devices 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:

K062583

Device Name:

EliATM Celikey IgG

#### Indications For Use:

EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as the antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease. EliA Celikey IgG uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

Mona M. Chen
Division Sign-Off

Office of in Vitro Dlagnostic Device Evaluation and Safety

510(k) K062583

Prescription Use V (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 Device Evaluation (ODE)