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The Wako IgM II - HA test is an in vitro assay for the quantitative determination of immunoglobulin M in serum. Measurement of immunoglobulin M in serum for monitoring and prognosis of chronic liver diseases, infectious diseases, lymphocytosis, multiple myeloma, primary and secondary immune failure.

The Wako IgM II-HA test is an in vitro assay for the quantitative determination of immunoglobulin M in serum. When a sample is mixed with the Buffer solution and Anti-IgM, IgM in the sample combines specifically with anti-human IgM antibody in the Anti-IgM to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgM in the sample.

The provided 510(k) summary describes the Wako IgM II-HA test, an in vitro assay for the quantitative determination of immunoglobulin M in serum. The safety and effectiveness of this device are demonstrated by its substantial equivalency to a predicate device, the Wako IgM HA-Direct product.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The text only mentions "comparison studies against the predicate assay."
   • Data Provenance: Not explicitly stated. It is implied to be clinical samples, likely human serum, but details on origin (e.g., country) or whether they were retrospective/prospective are not provided.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Number of Experts: Not applicable or not stated. This device measures a quantitative analyte and typically relies on established reference methods or predicate devices to define "ground truth" for comparison, rather than expert interpretation.
   • Qualifications of Experts: N/A

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or interpretive tasks (e.g., image reading), not for quantitative analytical assays where comparison is made against a reference or predicate method.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was one done? No. MRMC studies are used for interpretive tasks involving human readers, which is not relevant for a quantitative in vitro diagnostic device like the Wako IgM II-HA test.
   • Effect size of human readers improvement: Not applicable.

5. Standalone (Algorithm Only without Human-in-the-Loop Performance) Study:

   • Was one done? Yes, effectively. The performance metrics (correlation, regression, precision, minimum detectable level) are reported for the Wako IgM II-HA test itself, independent of human interpretation or intervention beyond the assay's operational steps. The device itself is the "algorithm" in this context.

6. Type of Ground Truth Used:

   • Predicate Device/Reference Method: The "ground truth" for this device's performance evaluation was its substantial equivalency to the Wako IgM HA-Direct product. The predicate device's results served as the reference for comparison, indicating its established accuracy and reliability. While not explicitly stated, "precision studies" would also likely compare against internal quality control materials with known values.

7. Sample Size for the Training Set:

   • Not applicable. This is an immunoassay kit, not a machine learning algorithm that requires a "training set" in the computational sense. The device's performance characteristics are established through analytical verification and validation studies.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device. The accuracy of the Wako IgM HA-Direct product (the predicate device) would have been established through its own rigorous validation studies at the time of its market clearance.

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