(52 days)
FREELITE® Human Kappa Free Kit For Use on the Olympus AU analyzer. This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
FREELITE® Human Lambda Free Kit For Use on the Olympus AU analyzer. This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
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This document is a FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, not a study report or scientific publication describing acceptance criteria and a study to prove a device meets them. Therefore, many of the requested items are not present in this type of document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed performance data provided by the manufacturer and determined that the new device performs as well as, or is sufficiently similar to, a device already on the market. The specific acceptance criteria and the detailed study proving equivalence are typically included in the 510(k) submission itself, which is not fully provided here.
However, based on the information that is available in this clearance letter, here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
This information is not provided in this FDA clearance letter. The letter confirms that The Binding Site, Limited’s FREELITE® Human Kappa and Lambda Free Kits for Use in the Olympus AU series Analyzers are substantially equivalent to predicate devices. The specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) and their acceptance criteria would have been part of the 510(k) submission, which is not contained within this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in this FDA clearance letter. Such details would be found within the 510(k) submission document.
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)
This information is not provided in this FDA clearance letter. For IVD devices like this, ground truth is typically established through reference methods or clinical diagnosis, not by experts reviewing images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in this FDA clearance letter. As above, adjudication methods like 2+1 or 3+1 are more relevant to image-based diagnostic aids and not typically for quantitative IVD tests where results are numerical values.
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/Not provided. This is an in vitro diagnostic (IVD) device for quantitating kappa and lambda free light chains in serum and urine. It is not an AI-assisted diagnostic tool for human readers; therefore, an MRMC comparative effectiveness study involving human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is inherently standalone. This is an automated in vitro diagnostic test performed on an analyzer. The "algorithm" is the reagent and analyzer system itself, producing quantitative results. Its performance is evaluated in a standalone manner. The FDA's substantial equivalence determination is based on the performance of the device as a system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used is not explicitly stated in this letter. For an IVD device quantifying biomarkers, the ground truth would typically be established by:
- Reference methods: A highly accurate and precise analytical method.
- Clinical diagnosis/Patient outcomes: Correlating the device's results with the ultimate clinical diagnosis of conditions like "lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus."
8. The sample size for the training set
Not applicable/Not provided. This device is a reagent/analyzer system, not an AI model that requires a "training set" in the conventional machine learning sense. The development of such a system involves analytical validation and clinical validation, but not typically a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable/Not provided. As explained in point 8, this is not an AI-based device that relies on a "training set" and corresponding ground truth for algorithm development.
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).