Celikey IgG is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgG antibodies in human serum and plasma. 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.

Device Description

Celikey IgG is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of tTG (IgG) antibodies in human serum or plasma. Antibodies specific for tTG present in the patient sample bind to the antigen.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Celikey® IgG tTG Antibody Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Celikey® IgG tTG Antibody Assay. Instead, it frames the performance evaluation in terms of comparability to a predicate device and meeting "state-of-the-art expectations" and "medical literature" expectations.

Therefore, the table will reflect the general performance goals described rather than hard numerical thresholds.

Acceptance Criteria (Implied)	Reported Device Performance
Comparability to predicate device (INOVA QUANTA Lite™ h-tTG IgG) in analyzing positive, equivocal, and negative sera.	Supported by data set showing comparability across positive, equivocal, and negative sera.
Expected performance for clinically defined sera.	Data shows the assay performs as expected for clinically defined sera.
Expected performance for samples from apparently healthy subjects (normal population).	Data shows the assay performs as expected for samples from apparently healthy subjects.
Substantial equivalence to the predicate device.	All available data support substantial equivalence to the predicate device.
Performance according to state-of-the-art expectations.	All available data support performance according to state-of-the-art expectations.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The text states "a data set including… results obtained within a comparison study analyzing positive, equivocal and negative sera," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." However, the specific number of samples in each of these categories, or the total sample size for the test set, is not provided in the given document.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study focuses on comparing the new device to a predicate device and clinically defined sera, but it doesn't detail the method of establishing the "ground truth" for those comparisons, nor does it mention expert involvement for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) assay designed to measure antibodies, not an imaging device or a device requiring human interpretation of complex visual data where MRMC studies are typically employed to assess reader performance.
Effect size of human readers with vs. without AI assistance: Not applicable, as this is an IVD assay.

6. Standalone (Algorithm Only) Performance

Was it done? Yes, in a sense, the primary evaluation presented is of the device's standalone performance. The "comparability study" assesses the Celikey IgG device's ability to produce results akin to the predicate device, and its performance with clinically defined and healthy samples. This is a measure of the algorithm's (or assay's) output without a human in the loop interpreting the raw measurement. The device itself generates the semi-quantitative and qualitative results.

7. Type of Ground Truth Used

Based on the description:

Comparison to a predicate device: The results from the INOVA QUANTA Lite™ h-tTG IgG assay served as a form of reference or "truth" for comparability.
Clinically defined sera: This implies that the samples had a known clinical status (e.g., celiac disease positive or negative) established by other diagnostic means (which are not specified but could include biopsy, other antibody tests, or clinical presentation).
Samples from apparently healthy subjects (normal population): These samples are expected to be negative for the target antibodies, effectively serving as a negative ground truth.

Therefore, the ground truth is a combination of comparison to a legally marketed predicate device and clinically defined (diagnosed) patient status, along with samples from a normal population.

8. Sample Size for the Training Set

This information is not provided in the document. IVD assays like this typically undergo extensive development and validation, but the specific details of a "training set" (in the machine learning sense) are not outlined, nor are the "training" samples or their number explicitly stated.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as details about a "training set" for the assay's development or the method of establishing its ground truth are not included.

Summary

{0}------------------------------------------------

Celikey® IgG tTG (human, recombinant) IgG Antibody Assay – New Device 510(k) Submission Section 9. Summary of Safety and Effectiveness

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:	K04/1173
Date of Summary Preparation:	April 28, 2004
Manufacturer:	Sweden Diagnostics (Germany) GmbHMunzinger Strasse 7D-79111 Freiburg, Germany
Company Contact Person:	Michael LinssManager, Compliance and QualitySweden Diagnostics (Germany) GmbHMunzinger Strasse 7D-79111 Freiburg, Germany+49-761-47805-310(Phone)+49-761-47805-335 (Fax)
Device Name:	Celikey ® IgG Tissue TransglutaminaseIgG Antibody Assay
Common Name:	Tissue transglutaminase IgG autoantibodyimmunological test system
Classification

Classification

Product Name	Product Code	Class	CFR
Celikey® IgG TissueTransglutaminase IgGAntibody Assay	MVM	II	866.5660

Substantial Equivalence to

{1}------------------------------------------------

Intended Use Statement

General Description of the Device

Celikey® IgG tTG IgG Antibody Assay Test Principle

Celikey IgG is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of tTG (IgG) 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 IgG antibodies to tissue transglutaminase (endomysium) in human serum. Both assays recommend the same sample dilutions and use comparable antigens and detection systems.

In accordance to the relevant scientific literature both assays state in the Intended Use, that the measuring of the IgG 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 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 strong positive. The new device uses a set of six Calibrators and classifies the results as negative, equivocal and positive.

{2}------------------------------------------------

Laboratory equivalence

The comparability of INOVA QUANTA Lite™ h-tTG IgG and Celikey® IgG tTG IgG Antibody assay 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 samples from apparently healthy 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 equivalent to the predicate device and that the new device performs according to state-of-the-art expectations.

{3}------------------------------------------------

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 caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 2 2004

Michael Linss. Ph.D Manager. Compliance and Quality Sweden Diagnostics (Germany) GmbH Munzinger Strasse 7 Munzinger Strasse GEERMANY

K041173 Re:

K041173
Trade/Device Name: Celikey® IgG Tissue Transglutaminase (human, recombinant) IgG Antibody Assay Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: July 12, 2004 Received: July 14, 2004

Dear Dr. Linss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 3 re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to May 2011/09/2017 accordance with the provisions of the Federal Food, Drug, devices that have been roomstilled in quire approval of a premarket approval application (PMA). and Cosmetic rear (110-) that so nevice, subject to the general controls provisions of the Act. The r ou may, dierelere, mains of the Act include requirements for annual registration, listing of general controll pro resuring 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 It may be subject to back date 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 lease be devisou that i Drimination that your device complies with other requirements of the Act that I Dri has Intact and regulations administered by other Federal agencies. You must or any I edetal statutes and securitements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CI IC Part 6077, adoming (DI Corporation (QS) regulation (21 CFR Part 820). This letter requirences as out form interior your device as described in your Section 510(k) premarket wifi anow you to begin mativeing of substantial equivalence of your device to a legally marketed

{4}------------------------------------------------

Page 2

If you desire specific information about the application of labeling requirements to your device, II you desire specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the vitto Diagnostic Dover Better Landing by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the 1 ou may other general miermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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

{5}------------------------------------------------

Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Celikey® IgG Tissue Transglutaminase (human, recombinant) IgG Antibody Assay

Indications For Use:

Celikey IgG is intended for the semiquantitative and qualitative measurement of anti-Celikey IgO is intendod for the sonaquisodies in human serum and plasma. Celikey IgG tissue transgratuminabe (11 0) 25 - 25 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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)

Mana M Clon

Division Sign-Off

Page 1

Office of In Vitro Diagnostla Device Evaluation and Safety

iki K041173

Regulation Number and Section

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
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).(b)
Classification. Class II (performance standards).