(89 days)
No
The description details a standard enzyme immunoassay (ELISA) kit for antibody detection, which does not inherently involve AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for diagnostic purposes, specifically for measuring antibodies to aid in the clinical diagnosis of celiac disease, rather than providing therapy.
Yes
The product information explicitly states, "Celikey IgG...is useful as an aid in the clinical diagnosis of patients with celiac disease." This indicates its role in identifying or confirming the presence of a disease, which is the definition of a diagnostic device.
No
The device description clearly states that the device is an enzyme immunoassay test kit containing physical components such as microplate strips, calibrators, controls, and reagents. This indicates it is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "measurement of anti-tissue transglutaminase (tTG) IgG antibodies in human serum and plasma." This involves testing a sample taken from the human body in vitro (outside the body).
- Aid in Clinical Diagnosis: The intended use also states it's "useful as an aid in the clinical diagnosis of patients with celiac disease." This is a key characteristic of IVD devices, which are used to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test kit that uses an "indirect noncompetitive enzyme immunoassay" to detect antibodies in "human serum or plasma." This is a typical format for an IVD test.
- Components: The list of components (microplate strips, calibrators, controls, reagents) are all standard elements of an IVD test kit.
The information provided clearly indicates that this device is designed to be used in vitro to analyze human samples for diagnostic purposes, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MVM
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. 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041173
INOVA QUANTA Lite™ h-tTG IgG
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) GmbH |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| Company Contact Person: | Michael Linss |
| Manager, Compliance and Quality | |
| Sweden Diagnostics (Germany) GmbH | |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| +49-761-47805-310(Phone) | |
| +49-761-47805-335 (Fax) | |
| Device Name: | Celikey ® IgG Tissue Transglutaminase |
| IgG Antibody Assay | |
| Common Name: | Tissue transglutaminase IgG autoantibody |
| immunological test system | |
| Classification |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Celikey® IgG Tissue | |||
| Transglutaminase IgG | |||
| Antibody Assay | MVM | II | 866.5660 |
Substantial Equivalence to
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Intended Use Statement
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.
General Description of the Device
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.
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.
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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