(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.
§ 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).