(102 days)
EliA Celikey IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgA 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 IgA uses the EliA IgA method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to tissue transglutaminase (tTG) and gliadin with ImmunoCAP 100 or 250 using the EliA IgG or IgA method.
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 IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgA calibration is based on a set of six WHO-standardized IgA 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.
The provided text describes the EliA™ Celikey IgA Immunoassay and EliA™ Celiac Control, which are devices intended for the in vitro semi-quantitative measurement of IgA antibodies to tissue transglutaminase (tTG) in human serum and plasma as an aid in diagnosing celiac disease. The submission, however, states that studies were conducted to demonstrate laboratory equivalence to the predicate device, not to establish specific acceptance criteria for diagnostic performance (such as sensitivity or specificity) in a clinical population or to prove the device meets such criteria through a dedicated study.
The document focuses on demonstrating substantial equivalence to an existing predicate device (Celikey Tissue Transglutaminase (human, recombinant) IgA Antibody Assay, K041174) rather than establishing novel performance standards. The "study" mentioned generally refers to demonstrating this equivalence.
Here's an attempt to extract and interpret the requested information, with the understanding that specific diagnostic performance metrics against acceptance criteria are not explicitly detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the focus on substantial equivalence and laboratory equivalence in the provided text, explicit acceptance criteria tied to diagnostic performance metrics (like sensitivity, specificity, accuracy against a gold standard) are not stated in the typical format of a clinical trial. Instead, the "acceptance criteria" appear to be met by demonstrating comparability and linearity with the predicate device across various sample types.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Comparability with Predicate Device | All available data support that the new device is substantially equivalent to the predicate device, including a comparison study, results from clinically defined sera, and results from apparently healthy subjects. |
| Linearity/Correlation | (Not explicitly detailed, but implied by 'comparison study' and 'laboratory equivalence') |
| Precision/Reproducibility | (Not explicitly detailed, but likely part of 'laboratory equivalence' assessment) |
| Performance in specific clinical populations | Results obtained for clinically defined sera, and samples from apparently healthy subjects. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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)."
- Sample Size for Test Set: Not explicitly stated. The text refers generally to "a data set" and "samples" without providing specific numbers for the comparison study, clinically defined sera, or healthy subjects.
- Data Provenance: Not explicitly stated. The document doesn't mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document focuses on laboratory comparisons and substantial equivalence, not on establishing a ground truth for diagnostic accuracy with a panel of experts. The "ground truth" for demonstrating equivalence would refer to the established values from the predicate device and the clinical classification of samples (e.g., "clinically defined sera" for celiac patients vs "apparently healthy subjects").
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as the study described is not a clinical trial requiring such a process for diagnostic endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The device in question is an automated immunoassay system, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone Performance Study Was Done
Yes, in a sense, the "comparison study between new and predicate device" and the assessment with "clinically defined sera" and "samples from apparently healthy subjects" represent a standalone performance evaluation of the new device's results compared to either the predicate device's results or established clinical categories. However, it's not a standalone study purely for diagnostic accuracy against a definitive clinical gold standard with specific sensitivity/specificity targets outlined in the text. The primary goal was to show equivalence to the predicate.
7. The Type of Ground Truth Used
The "ground truth" for the equivalence studies appears to be based on:
- Predicate Device Results: The results generated by the legally marketed predicate device (Celikey Tissue Transglutaminase (human, recombinant) IgA Antibody Assay, K041174).
- Clinical Classification: The clinical status of the samples, i.e., "clinically defined sera" (presumably from celiac patients confirmed by other means) and "samples from apparently healthy subjects."
8. The Sample Size for the Training Set
Not applicable. The document does not discuss a training set for an algorithm. This device is an immunoassay, not a machine learning or AI-based system that requires a distinct training phase in the same sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" for an algorithm described in the context of this device.
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DEC 2 9 2006 --
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS の。
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:
$K062787$
Date of Summary Preparation September 15, 2006
Manufacturer:
510 (k) Contact Person:
Device Name:
Common Name:
Phadia AB
Rapsgatan 7
SE-751 37 Uppsala, Sweden
Martin Mann
Regulatory Affairs Manager
Phadia US Inc.
4169 Commercial Avenue
Portage, Mi 49002, USA
+1 (-269-492)-1957 (Phone)
+1 (-269-492)-7541 (Fax)
martin.mann@phadia.com
EliA™ Celikey IgA Well
EliA™ Celiac Control
Tissue transglutaminase autoantibodies
immunological test system, Antigen and Control
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| EliA™ Celikey IgA | MVM | II | 866.5660 |
| EliA™ Celiac Control | MVM | II | 866.5660 |
Substantial Equivalence to
Celikey Tissue Transglutaminase (human, recombinant) IgA Antiboody Assay 510(k) number: K041174
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Intended Use Statement of the New Device
EliA Celikey IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgA 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 IgA uses the EliA IgA method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to tissue transglutaminase (tTG) and gliadin with ImmunoCAP 100 or 250 using the EliA IgG or IgA method.
Special condition for use statement
The device is for prescription use only.
Special instrument requirements
ImmunoCAP100/ImmunoCAP250 are fully automated immunoassay analyzers, which 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 IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgA calibration is based on a set of six WHO-standardized IgA 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 IgA 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 IgA antibodies (EliA IgA 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
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fluorescence in the reaction mixture is measured. The higher the response value, the more specific IgA is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.
Device Comparison
The new and the predicate device both represent non-competitive solid phase EIAs. Both IVDs are used as an and 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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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 eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Martin R. Mann Phadia US Inc. 4169 Commercial Ave. Portage, MI 49002
DEC 2 9 2006
Re: K062787 Trade/Device Name: EliA™ Celikey IgA Immunoassay, EliA™ Celiac Control Regulation Number: 21 CFR 866.5660 Regulation Name: Tissue transglutaminase autoantibodies immunological test system, Antigen and Control Regulatory Class: Class II Product Code: MVM Dated: September 15, 2006 Received: September 18, 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 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).
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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 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 (240) 276-0490. 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 Rockerf
Robert L. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation & Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
062787
Device Name:
EliA™ Celiac Control
Indications For Use:
EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to tissue transglutaminase (tTG) with ImmunoCAP 100 or 250 using the EliA IgG or IgA method.
Robert M. Becker
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510k: K062787
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)
Page 2
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Indications for Use
510(k) Number:
c2787
Device Name:
EliATM Celikey IgA Immunoassay
Indications For Use:
EliA Celikey IgA Immunoassay is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase (tTG) in human serum and plasma (EDTA, citrate). EliA Celikey IgA Immunoassay is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease, in conjunction with other laboratory and clinical findings. EliA Celikey IgA Immunoassay uses the EliA IgA method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062787
Prescription Use V 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)
CONFIDENTIAL AND PROPRIETARY
Page l
§ 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).