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EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K102673, but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells: EliA RF IqM Wells are coated with aggregated rabbit IgG 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 IgM Method Reagents: EliA IgM Conjugate 50 or 200: ß-Galactosidase labeled anti-IgM (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 IgM Calibrator Strips: Human IgM (0, 10, 35, 80, 500, 1000 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 IgM Curve Control Strips: Human IgM (80 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 IgM 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 an EliA RF IgM test.

Here's a breakdown of the acceptance criteria and study information for the EliA RF IgM Immunoassay on the Phadia 2500/5000 instruments, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the EliA RF IgM Immunoassay, previously cleared on the Phadia 250 instrument (K102673), performs substantially equivalently when used on the new Phadia 2500/5000 instrument platform. Therefore, the acceptance criteria are primarily focused on method comparison and analytical performance to show this equivalence. No explicit "acceptance criteria" are provided as a single table within this document for each performance characteristic, but they are implied by the statistical analyses and cut-offs used.

Here's an organized table presenting the relevant acceptance criteria (implied or stated) and the reported device performance:

2. Sample Sizes and Data Provenance

• Precision Test Set Sample Size: Five samples (at various concentrations: 1.6, 3.9, 7.0, 73.7, 169.6 IU/mL). Each sample tested in four replicates/run, over 21 runs (3 instruments x 7 runs), totaling 84 replicates per sample.
• Linearity Test Set Sample Size: Four patient serum samples.
• Detection Limit (LoD/LoB) Test Set Sample Size: One blank sample (measured in 33 replicates in each of two runs) and three low-level samples (measured in 11 replicates in each of two runs). Total 66 blank determinations and 66 low-level determinations for LoD. 66 determinations for LoQ.
• Method Comparison Test Set Sample Size: More than 100 samples (with ≥20% of the samples within ±25% of the medical decision point).
• Expected Values/Reference Range Test Set Sample Size: n = 400 apparently healthy subjects.
• Data Provenance: Not explicitly stated for specific sample origins (e.g., country of origin, retrospective/prospective). The reference range study mentions "sera from a Caucasian population obtained from a blood bank," which implies a prospective collection for that specific study, but the overall patient samples used in other analytical studies are not detailed.

3. Number of Experts and Qualifications (Ground Truth Establishment for Test Set)

• Not Applicable: This submission is for an immunoassay, which detects specific antibodies in patient samples. The "ground truth" for such devices is established by the assay's ability to accurately measure the analyte (IgM class rheumatoid factor antibodies) and correlate with clinical diagnosis of rheumatoid arthritis, as per established medical criteria for the disease itself, not by expert consensus on image interpretation or similar qualitative assessments. For method comparison studies, the "ground truth" is essentially the result obtained by the predicate device (EliA RF IgM on Phadia 250).

4. Adjudication Method (for Test Set)

• Not Applicable: Adjudication methods (like 2+1 or 3+1) are typically used for qualitative assessments, such as image interpretation, where multiple experts provide independent reads that may then be reconciled. This device is a quantitative immunoassay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC study is not relevant for this type of in vitro diagnostic device (immunoassay). MRMC studies are used to assess the comparative effectiveness of different diagnostic methods (e.g., AI-assisted vs. unassisted human readers) using multiple readers and multiple cases, typically for image-based diagnostics.

6. Standalone Performance Study (Algorithm Only)

• Yes, implicitly: The entire submission describes the standalone performance of the device (EliA RF IgM Immunoassay on the Phadia 2500/5000 instrument) in terms of its analytical characteristics (precision, linearity, detection limits, method comparison to the predicate). There is no "human-in-the-loop" for this automated immunoassay; the result is generated by the instrument and its associated software based on the specimen's reaction.

7. Type of Ground Truth Used

• For Analytical Performance:
  • Predicate Device Results: For method comparison, the results obtained from the predicate device (EliA RF IgM on Phadia 250) served as the comparative "ground truth" against which the new instrument's results were evaluated for substantial equivalence.
  • Expected Values/Spiked Samples/Known Standards: For studies like linearity and precision, the "ground truth" is based on samples with known or expected concentrations, or samples created through controlled dilutions.
• For Clinical Relevance: While the direct analytical studies here used the predicate as a reference, the original clinical performance values for the EliA RF IgM immunoassay were "reviewed in K102673," which would have established its "aid in diagnosis" claim against clinical findings of rheumatoid arthritis.

8. Sample Size for the Training Set

• Not Applicable in the traditional sense: This device is an immunoassay, not an AI/ML algorithm that undergoes a distinct "training phase" on a dataset in the way an imaging algorithm would. The development of an immunoassay involves optimization of reagents and protocols, which is a different process than "training" an algorithm. The 510(k) process focuses on demonstrating analytical and clinical performance for regulatory clearance.

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

• Not Applicable: As explained above, there is no traditional "training set" or "ground truth for a training set" as it would apply to an AI/ML device. The "ground truth" related to the assay's development (optimization, reagent formulation, etc.) would stem from biochemical principles, manufacturing specifications, and initial performance evaluations to ensure the assay functions as intended before formal validation studies.

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