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EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K082759 (EliA CENP and EliA U1RNP) and K083117 (EliA RNP70), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells:

• EliA CENP Wells are coated with human recombinant centromere protein B 2 carriers (12 wells each), ready to use;
• -EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A. C) proteins- 4 carriers (12 wells each), ready to use;
• -EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein-4 carriers (12 wells each), ready to use;

EliA Sample Diluent:

• -EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use:

EliA IgG reagents:

• EliA IgG Coniugate 50 or 200: ß-Galactosidase labeled anti-laG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide -6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
• EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
• EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.

The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA CENP, EliA U1RNP and EliA RNP70 tests.

The provided FDA 510(k) summary for the EliA CENP, EliA U1RNP, and EliA RNP70 Immunoassays on the Phadia 2500/5000 instrument describes analytical performance studies, not typically studies involving human readers or expert adjudication in the context of AI/ML devices. Therefore, several of the requested sections below are marked as "Not Applicable (N/A)" because this document pertains to an in vitro diagnostic (IVD) assay and instrument combination, not an AI/ML-driven imaging or diagnostic device requiring human reader studies or expert adjudication of image-based ground truth.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for EliA CENP, EliA U1RNP, and EliA RNP70 Immunoassays on Phadia 2500/5000

The acceptance criteria for this device are demonstrated through various analytical performance metrics, primarily comparing the new instrument platform (Phadia 2500/5000) to a predicate device (Phadia 250). The performance data below focuses on precision, linearity, detection limits, and method comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "acceptance criteria" through the results of pre-specified analytical performance studies (precision, linearity, and method comparison), demonstrating the new device's equivalence to the predicate. The "acceptance criteria" are explicitly stated for the method comparison as "the slope for the regression lines should be 0.9 - 1.1 for single replicate to single replicate and intercept close to 0." For Other performance characteristics, the "acceptance" is implied by the presentation of the results, indicating they met the manufacturer's internal standards for demonstrating substantial equivalence.

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

• Sample Size (Method Comparison): More than 100 samples for each EliA test (CENP, U1RNP, RNP70).
• Sample Size (Precision): 5 different samples were tested for each immunoassay. Each sample was tested in four replicates/run, over 21 runs (3 instruments x 7 runs), resulting in 84 replicates per sample.
• Sample Size (Linearity): Four patient serum samples were diluted for each immunoassay.
• Sample Size (Detection Limit): One blank sample (66 determinations) and three low-level samples (66 determinations) were used for LoD/LoQ studies for each immunoassay.
• Sample Size (Expected Values/Reference Range): 400 serum samples from an apparently healthy Caucasian population for each immunoassay.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples, but the reference populations for "Expected Values" are described as "Caucasian population obtained from a blood bank." The studies described appear to be prospective analytical studies conducted by the manufacturer to support the 510(k) submission for the new instrument platform.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• N/A. This is an IVD device measuring antibody levels, not an AI/ML device that requires expert human interpretation of images or clinical data for ground truth. The "ground truth" for these tests is the value measured by the predicate device and the analytical standards (e.g., linearity standards, controls).

4. Adjudication Method for the Test Set

• N/A. No expert adjudication process is described as this is an IVD device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A. This is an IVD device, not an AI-assisted diagnostic tool involving human readers of images or other complex data. The comparison is between an older instrument (Phadia 250) and a new instrument (Phadia 2500/5000) running the same assays.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• N/A. This is an IVD device, not an AI algorithm. The performance described is the standalone analytical performance of the instrument/assay combination.

7. The Type of Ground Truth Used

• For the method comparison studies, the "ground truth" or reference method was the predicate device (Phadia 250 instrument) running the same assays. The goal was to show substantial equivalence between the new and predicate instruments.
• For analytical performance characteristics (precision, linearity, detection limits), the ground truth is established through standard laboratory practices using calibrators, controls, and reference materials as per CLSI guidelines, which are themselves traceable to established measurement procedures.

8. The Sample Size for the Training Set

• N/A. This document describes performance validation of an IVD assay/instrument system, not the training of an AI/ML model. Therefore, there is no "training set" in the AI/ML sense. The device is a measurement system; it does not "learn" from data.

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

• N/A. As there is no AI/ML training set, this question is not applicable. The device's "ground truth" (its measurement accuracy) is established through rigorous analytical validation studies using controls, calibrators, and comparison to validated predicate methods, not through a "training set" of patient data.

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