CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

K041174 · Sweden Diagnostics (Germany) GmbH · MVM · Jul 19, 2004 · Immunology

Device Facts

• Record ID: K041174
• Device Name: CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
• Applicant: Sweden Diagnostics (Germany) GmbH
• Product Code: MVM · Immunology
• Decision Date: Jul 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Celikey® tTG (human, recombinant) IgA Antibody Assay is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma. Celikey is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.

Device Story

Celikey tTG IgA Antibody Assay is an indirect noncompetitive ELISA kit; uses microplate wells coated with recombinant human tTG antigen. Patient serum or plasma samples are added; specific anti-tTG IgA antibodies bind to immobilized antigen. Unbound material is washed away; horseradish peroxidase-conjugated anti-human IgA is added to form enzyme-labeled conjugate-antibody-antigen complexes. After further washing, TMB substrate is added; color formation rate is proportional to autoantibody concentration. Used in clinical laboratories; results interpreted by healthcare providers to aid celiac disease diagnosis. Kit includes calibrators, positive/negative controls, wash buffer, sample diluent, and stop solution.

Clinical Evidence

Clinical performance was evaluated by comparing the subject device to the predicate using a dataset including positive, equivocal, and negative sera, clinically defined sera, and samples from a normal population. Results demonstrated that the assay performs as expected based on medical literature and is substantially equivalent to the predicate.

Technological Characteristics

Indirect noncompetitive enzyme immunoassay (EIA). Components: microplate strips coated with purified human recombinant tTG antigen, calibrators, controls, enzyme-labeled conjugate, substrate, stop solution, diluent, and wash buffer. Detection system based on colorimetric enzyme-substrate reaction. Analyte: IgA antibodies against tissue transglutaminase.

Indications for Use

Indicated for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies 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

• INOVA QUANTA Lite™ tTG

Submission Summary (Full Text)

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JUL 1 9 2004

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

This summary of safety and effectiveness information is being submitted in Inis summary of sacty and Check . The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

| Assigned 510(k) Number: | K041174 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | April 28, 2004 |
| Manufacturer: | Sweden Diagnostics (Germany) GmbH<br>Munzinger Strasse 7<br>D-79111 Freiburg, Germany |
| Company Contact Person: | Michael Linss<br>Manager, Compliance & Quality<br>Sweden Diagnostics (Germany) GmbH<br>Munzinger Strasse 7<br>D-79111 Freiburg, Germany<br>[phone] (Phone)<br>[phone] (Fax) |
| Device Name: | Celikey® Tissue Transglutaminase<br>(human, recombinant) IgA Antibody Assay |
| Common Name: | Tissue transglutaminase autoantibodies<br>immunological test system |

## Classification

| Product Name | Product Code | Class | CFR |
|------------------------------------------------------------|--------------|-------|----------|
| Celikey® tTG (human,<br>recombinant)<br>IgA Antibody Assay | MVM | II | 866.5660 |

### Substantial Equivalence to

INOVA QUANTA Lite™ tTG

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#### Intended Use Statement

Celikey is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma. Celikey is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.

## General Description of the Device

Celikey is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgA antibodies against Tissue transglutaminase in human serum or plasma.

The test kit contains microplate strips coated with purified human recombinant tTG antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.

## Celikey® tTG IgA Antibody Assay Test Principle

Celikey is an indirect noncompetitive enzyme immunoassay for the semiguantitative and qualitative determination of tTG (IgA) antibodies in human serum or plasma. The wells of a microplate are coated with recombinant human tTG antigen. Antibodies specific for tTG present in the patient sample bind to the antigen.

In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.

The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.

## Device Comparison

Both assays (the predicate and the new device) are indirect noncompetitive enzyme immunoassays for the semi-quantitative and qualitative determination of IgA antibodies to tissue transglutaminase (endomysium) in human serum. Both assays recommend the same sample dilutions and use comparable detection systems.

In accordance to the relevant scientific literature both assays state in the Intended Use, that the measuring of the IgA antibodies against tissue transglutaminase provides aid in the diagnosis of patients with celiac disease.

A difference between both assays is that the predicate device is only recommended for use in serum specimen while the new device is, intended for use with serum and plasma.

The predicate device uses a purified antigen from guinea pig liver whereas the new device is based on a recombinant human tTG antigen.

The cut-off in the predicate device assay is evaluated by using a low and a high positive Standard and a grading of the results in negative, weak, moderate and

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strong positive. The new device uses a set of six Calibrators and classifies the results as negative, equivocal and positive.

# Laboratory equivalence

The comparability of INOVA QUANTA Lite™ tTG and Celikey® tTG IgA The Comparasy is supported by a data set including

- · results obtained within a comparison study analyzing positive, equivocal and negative sera.
- · results obtained for clinically defined sera.
- · results obtained for emisears and any and any subjects (normal population).

The data show that the assay performs as expected from the medical literature.

In summary, all available data support that the new device is substantially In Sunmal y, an available data sapp on that the new device performs according to state-of-the-art expectations.

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JUL 1 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Michael Linss, Ph.D. Manager, Compliance and Quality Sweden Diagnostics (Germany) GmbH Munzinger Strasse 7 D-79111 Freiburg i. Br., Germany

Re: k041174 Trade/Device Name: Celikey® Tissue Transglutaminase (human, recombinant) IgA Antibody Assay Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies immunological test system Regulatory Class: II Product Code: MVM Dated: July 8, 2004 Received: July 12, 2004

Dear Dr. Linss:

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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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,

Robert L. Becker Jr.

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

K041174 510(k) Number:

Device Name: Celikey® Tissue Transglutaminase (human, recombinaut) IgA Antibody Assay

#### Indications For Use:

Celikey is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma. Celikey is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.

Prescription Use V (Per 21 CFR 801.109)

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)

Marie chan
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041174