(75 days)
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No
The summary describes a standard enzyme immunoassay kit and does not mention any AI or ML components or functionalities.
No.
The device is an in vitro diagnostic test for measuring antibodies related to celiac disease, used as an aid in diagnosis, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section states that Celikey "is useful as an aid in the clinical diagnosis of patients with celiac disease." This clearly indicates its role in diagnosis.
No
The device description explicitly states that the test kit contains physical components such as microplate strips, calibrators, controls, and various solutions, indicating it is a hardware-based immunoassay kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma." This involves testing biological samples (serum and plasma) 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 IVDs – they provide information to help diagnose or manage a medical condition.
- Device Description: The description details an "indirect noncompetitive enzyme immunoassay" using components like microplate strips, calibrators, controls, and reagents. This is a typical format for laboratory-based diagnostic tests performed in vitro.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MVM
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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 |
| Munzinger Strasse 7 | |
| D-79111 Freiburg, Germany | |
| Company Contact Person: | Michael Linss |
| Manager, Compliance & 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® Tissue Transglutaminase |
| (human, recombinant) IgA Antibody Assay | |
| Common Name: | Tissue transglutaminase autoantibodies |
| immunological test system |
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| Celikey® tTG (human, | |||
| recombinant) | |||
| 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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 (301) 594-3084. 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 (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
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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