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Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers.

Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The Tina-quant IgM Gen.2 is an immunoturbidimetric assay. Anti-IgM antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

The Acceptance Criteria for the "Tina-quant IgM Gen.2" device are not explicitly detailed in the provided text in a quantitative manner (e.g., specific thresholds for accuracy, precision, or comparison to a gold standard). However, the document does describe the performance characteristics of the device, particularly its measuring range, and indicates its substantial equivalence to a predicate device.

The study presented focuses on demonstrating substantial equivalence to the predicate device, "Roche Diagnostics Tina-quant IgM assay" (K955908). The key performance aspect discussed is the measuring range.

Here's an attempt to structure the information based on the provided text, recognizing that some of the requested categories are not explicitly covered due to the nature of a 510(k) summary for an in vitro diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document (510(k) summary for an in vitro diagnostic device), "acceptance criteria" are implied by the performance characteristics presented and the claim of substantial equivalence to a predicate device. The primary performance characteristic highlighted for comparison is the measuring range.

Note: The "acceptance criteria" for an IVD device in a 510(k) would typically involve demonstrating comparable performance (e.g., accuracy, precision, linearity, interference) to a legally marketed predicate device. The document primarily focuses on outlining the device's characteristics and asserting substantial equivalence rather than listing specific numerical acceptance thresholds. The improved/expanded measuring range and additional pediatric expected values for the Gen.2 device are presented as enhancements while maintaining the core functionality.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically found in the full study report, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For an in vitro diagnostic test for IgM levels, the "ground truth" would be established through established analytical methods and reference materials, not expert consensus in the way it would be for image interpretation or clinical diagnosis. The document does not mention experts establishing ground truth for a test set.

4. Adjudication method for the test set

Not applicable. The concept of adjudication (e.g., 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, not for a quantitative in vitro diagnostic device like this IgM assay.

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

Not applicable. An MRMC comparative effectiveness study is relevant for devices involving human interpretation, often in imaging or diagnostic assistance, usually with AI. This document pertains to an automated, quantitative immunoassay, which does not involve human "readers" in the diagnostic process beyond interpreting the numerical result.

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

Yes, this is essentially a standalone (algorithm/device only) performance assessment. The "Tina-quant IgM Gen.2" is an automated immunoturbidimetric assay. Its performance is measured directly by its analytical capabilities (measuring range, accuracy, precision, etc.), without human "in-the-loop" interpretation of the primary measurement signal. The results are quantitative numerical values.

7. The type of ground truth used

The ground truth for such an in vitro diagnostic device is implicitly established through reference materials, calibrators, and well-characterized samples with known IgM concentrations, traceable to international standards where available. The document does not explicitly state the specific type of ground truth beyond the general analytical methods.

8. The sample size for the training set

The document does not specify the sample size for any training set. For an IVD, "training set" might refer to samples used during reagent development and initial analytical validation, but this information is not provided.

9. How the ground truth for the training set was established

The document does not specify how the ground truth for a training set (if one was formally used in a machine learning sense, which is unlikely for this type of assay) was established. As mentioned in point 7, the ground truth for an IVD is typically based on analytical reference methods and calibrators.

Ask a specific question about this device

This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation. This kit could be a useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and performance metrics for the SPIFE – Urine Immunofixation Electrophoresis Kit.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It states the indications for use of the device but does not include:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Details about expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or how it was established for either test or training sets.

Therefore, I cannot fulfill your request based on the information provided.

Ask a specific question about this device

Ask a specific question about this device