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EliA Gliadin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in serum or plasma to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin 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.

EliA Gliadin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in serum or plasma to aid in the diagnosis of celiac disease, in conjunction with other laboratory and clinical findings. EliA Gliadin IgG uses the EliA IgG method on the instruments 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.

EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to 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 be measured in defined ranges to check whether 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 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 IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG 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 be measured in defined ranges to check whether 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 is a 510(k) summary for medical devices (EliA™ Gliadin IgA, EliA™ Gliadin IgG, and EliA™ Celiac Control). It focuses on establishing substantial equivalence to predicate devices, rather than defining specific acceptance criteria for performance relative to a clinical outcome or a new benchmark. It does not contain information about studies designed to meet predefined acceptance criteria in the way a clinical trial for a new therapeutic or diagnostic might.

However, based on the information provided, we can infer the "acceptance criteria" and "study" in the context of this 510(k) submission as demonstrating laboratory equivalence to the predicate devices.

Here's an attempt to structure the information as requested, understanding that the context is a 510(k) for substantial equivalence, not a standalone performance study with explicit clinical acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria (Laboratory Equivalence Study)

The study described is a comparative study for laboratory equivalence between the new devices (EliA™ Gliadin IgA and EliA™ Gliadin IgG) and their respective predicate devices (Varelisa Gliadin IgA Antibodies and Varelisa Gliadin IgG Antibodies).

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a data set including results obtained within a comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." However, specific numbers for these sample sets are not provided.
• Data Provenance: Not explicitly stated. The manufacturer is Phadia AB from Sweden, but the origin of the clinical samples (e.g., country of origin) is not mentioned. It is implicitly a retrospective analysis of existing samples since the data is "obtained" and used for comparison, rather than a prospective clinical trial.

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 laboratory equivalence to a predicate device, not on diagnostic accuracy against a definitive clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided as the study design is centered on laboratory test comparison rather than expert review or adjudication of diagnostic outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted. This type of study (comparing human readers with and without AI assistance to improve diagnostic accuracy) is not relevant to this device, which is an in vitro diagnostic (immunoassay) and not an image-interpretation AI tool. The document focuses on the performance of the assay itself.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone in vitro diagnostic assay (a laboratory test kit processed on an automated instrument). The "study" was a standalone performance evaluation in the sense that it assessed the assay's output directly, comparing it to the predicate device's output, without human interpretation of raw data but with human involvement in running the test and interpreting final numerical results.

7. The Type of Ground Truth Used

The "ground truth" in this context is primarily the results obtained from the legally marketed predicate devices (Varelisa Gliadin IgA Antibodies and Varelisa Gliadin IgG Antibodies). Additionally, the study included "clinically defined sera" and "samples from apparently healthy subjects," implying that the clinical status of these patients might have served as a reference in a broader sense, though the primary comparison was assay-to-assay.

8. The Sample Size for the Training Set

This information is not applicable/not provided. These devices are immunoassay kits, not machine learning algorithms that require a "training set" in the computational sense. The term "training set" is typically used for AI/ML models. For IVDs, assay development involves optimization, but not typically a "training set" as understood in AI studies.

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

This information is not applicable for the same reasons as #8.

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