(468 days)
The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
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I'm sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance for an AI/ML medical device.
The document is an FDA 510(k) clearance letter for Diazyme Laboratories Inc.'s Human Kappa Free Light Chain Assay and Human Lambda Free Light Chain Assay. These are in-vitro diagnostic assays (laboratory tests), not AI/ML-based devices. The document primarily discusses:
- The FDA's review and determination of substantial equivalence for these specific assays.
- General regulatory requirements for medical devices (e.g., registration, labeling, good manufacturing practices).
- Indications for use for each assay (quantitative determination of Kappa/Lambda FLC concentrations in serum to aid in diagnosis and monitoring of multiple myeloma).
Therefore, I cannot extract the following information because it is not present in the provided text:
- A table of acceptance criteria and reported device performance (for an AI/ML device): The document does not describe performance metrics like sensitivity, specificity, AUC, etc., in the context of an AI/ML model for image or other data interpretation.
- Sample size used for the test set and data provenance: No mention of test sets for an AI/ML model.
- Number of experts used to establish ground truth and qualifications: This is irrelevant for a chemical assay.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as there is no AI assistance to human readers.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for chemical assays is typically established through reference methods and clinical correlations, not "expert consensus" in the way it's used for AI image analysis.
- Sample size for the training set: Not applicable for an IVD assay.
- How ground truth for the training set was established: Not applicable.
§ 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).