(123 days)
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BNTM Systems. Measurement of immunoglobulins aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF, IgG in urinc, transferrin in urine, albumin in urine and CSF, a1-microglobulin in urine and total protein in urine and CSF, using the BNTM Systems.
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM): Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
N/T Protein Control LC: The N/T Protein Control LC is a multi-analyte, lyophilized, polygeline and rabbit albumin based product.
The provided text describes a 510(k) summary for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) and N/T Protein Control LC. However, it does not contain detailed acceptance criteria and a study proving the device meets these criteria in the format requested.
The document primarily focuses on establishing substantial equivalence to previously marketed devices based on the general operating principle, reagent composition, and a single method comparison dato point. There is no mention of a traditional "acceptance criteria" table with specific thresholds for performance metrics (such as sensitivity, specificity, accuracy) and corresponding study results to demonstrate compliance.
Therefore, many of the requested sections, such as sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not available in the provided text.
Based on the available information, here's an attempt to answer the questions:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| For N Antisera to Human Immunoglobulins (IgG, IgA, IgM) - IgG in urine: | ||
| Correlation with Predicate | High correlation with legally marketed predicate (Beckman Coulter IMMAGE® IGU K951635) | Coefficient of Correlation: 0.99 (for IgG) |
| Regression: $y = 0.926 x - 0.34 mg/L$ | ||
| For N/T Protein Control LC - IgG in urine: | ||
| Substantial Equivalence to Predicate Control | Intended Use is substantially equivalent to predicate (Dimension Vista® Protein 3 Control K072435) | Modified N/T Protein Control LC demonstrated substantial equivalence in Intended Use to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The "Method Comparison Data" section does not provide these details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable / Not provided. This is a comparison of quantitative assays, not an expert-driven diagnostic review. The "ground truth" for the method comparison appears to be the results obtained by the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. Adjudication methods are typically relevant for expert review in image analysis or clinical diagnosis scenarios.
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. This is a submission for in vitro diagnostic reagents and controls, not an AI-assisted diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the N Antisera and N/T Protein Control LC reagents/systems) as a standalone diagnostic tool. The method comparison data is effectively a standalone performance assessment of the device against a predicate, focusing on quantitative agreement. The reported correlation coefficient of 0.99 for IgG demonstrates its standalone performance relative to the predicate.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the method comparison study was the measurements obtained from the legally marketed predicate device, the Beckman Coulter IMMAGE® Immunochemistry Systems Urine Immunoglobulin G (IGU) (K951635).
8. The sample size for the training set
Not applicable / Not provided. This is a traditional IVD device clearance, not an AI/machine learning device that would typically involve a separate "training set." The development of the reagents/system itself would have involved extensive R&D and calibration, but not in the context of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable / Not provided for the reasons stated in point 8.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).