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AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multicriterion diagnostic process, encompassing both clinical and laboratory-based assessments.

The AxSYM® Anti-CCP Standard Calibrators are for the standard calibration of the AxSYM System when used for the semi-quantitative determination the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma.

The AxSYM® Anti-CCP Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM Anti-CCP assay when used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System.

For in vitro diagnostic use.

AxSYM Anti-CCP is based on Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM Anti-CCP reagents and sample are pipetted in the following sequence:

SAMPLING CENTER

• . Sample and all AxSYM Anti-CCP reagents required for one test are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV),
• AxSYM Line Diluent and sample are pipetted into the Incubation Well of the . RV.
• . The AxSYM Anti-CCP Sample Diluent and diluted sample are pipetted into the Sample Well of the RV.
• . The AxSYM Anti-CCP Matrix Cell Blocker is pipetted into the Buffer Well of the RV.
• . The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase Conjugate is pipetted into Reagent Well 3 of the RV.
• . AxSYM Line Diluent and CCP-Coated Microparticles are pipetted into Reagent Well 2 of the RV.
• . A reaction mixture is formed by combining diluted sample and diluted microparticles coated with CCP in Reagent Well 1 of the RV.
• . When anti-CCP antibody is present in the sample, it binds to the CCP-Coated Microparticles, forming antigen-antibody complexes on the microparticles.

The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.

PROCESSING CENTER

• . An aliquot of Matrix Cell Blocker is transferred to the Matrix Cell.
• . An aliquot of the reaction mixture, containing microparticles and bound antigen-antibody complex, is transferred to the Matrix Cell. The microparticles bind irreversibly to the glass fiber matrix.
• The Matrix Cell is washed to remove materials not bound to the . microparticles.
• The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase . Conjugate is dispensed onto the Matrix Cell and it binds with the antigenantibody complexes.
• . The Matrix Cell is washed to remove conjugate not bound to the microparticles.
• . The substrate, 4-Methylumbelliferyl Phosphate, is added to the Matrix Cell. The alkaline phosphatase-labeled conjugate catalyzes the removal of a phosphate group from the substrate, yielding the fluorescent product, 4-Methylumbelliferone. This fluorescent product is measured by the MEIA optical assembly.

Here's an analysis of the provided text regarding the AxSYM® Anti-CCP device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated in numerical thresholds within the provided text. Instead, the submission claims substantial equivalence to a predicate device (DIASTAT™ Anti-CCP Assay, K023285) based on comparable performance metrics.

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

• Sample Size: The document does not explicitly state the total number of samples used for the clinical performance comparison. It only mentions "all samples tested" for the method comparison with 97.3% concordance, but the raw count is not provided.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The "ground truth" for evaluating the clinical performance of the AxSYM® Anti-CCP assay against the predicate device would typically involve a definitive diagnosis of Rheumatoid Arthritis (RA) or healthy controls, which should be established by qualified medical professionals. However, the document does not detail how this ground truth was established or the experts involved.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

• Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the performance of an in vitro diagnostic (IVD) assay, not a device requiring human interpretation of images or other data where reader variability would be a primary concern. The comparison is between two automated assays.
• Effect size of human readers with/without AI assistance: Not applicable, as this was not an MRMC study involving human readers and AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done for the AxSYM® Anti-CCP assay. The "Summary of Clinical Performance" directly reports on the performance of the AxSYM® Anti-CCP assay (e.g., its ROC AUC of 0.875) and compares it to the predicate device. This evaluation of the device's accuracy in distinguishing between patient populations is a form of standalone performance assessment.

7. Type of Ground Truth Used

The ground truth used for evaluating the clinical performance of the AxSYM® Anti-CCP assay (and the predicate DIASTAT™ Anti-CCP assay) would be the clinical diagnosis of Rheumatoid Arthritis (RA) and non-RA status of the patient samples. While the document doesn't explicitly state "pathology" or "outcomes data," the intended use as "an aid in the diagnosis of Rheumatoid Arthritis" implies that the samples used for validation were from individuals with confirmed RA and appropriate control groups.

8. Sample Size for the Training Set

The document does not report the sample size used for the training set. This submission is for a manufactured diagnostic kit, and the specifics of its internal algorithm development (including training data for the assay's cut-off determination or internal calibration) are not detailed.

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

The document does not report how the ground truth for the training set was established, as details about the device's internal development process are not included in this 510(k) summary.

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