(626 days)
The FLC Kappa kit is intended for the quantification of Kappa free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.
The FLC Lambda kit is intended for the quantification of Lambda free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.
The FLC Kappa and FLC Lambda test kits are intended for the quantification of free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure utilizing specific antibodies targeting anti-Lambda free light chains. It is carried out in 8 successive steps: Incubation of the previously diluted samples and calibrators, in the wells of the microplate, where specific free light chain antibodies are fixed. Washing of the wells to remove elements that have not been fixed by the anti-free light chain antiserum. Incubation with an anti- light chain antiserum (Kit specific) conjugated to peroxidase. Washing of the wells to remove the excess of antiserum conjugated to peroxidase. Incubation with peroxidase substrate. Stopping of the enzymatic reaction with an acidic solution. Reading of the optical density by absorbance spectrophotometry at 450 nm of the colored product. Calculation of the free light chain concentration of the sample using a calibration curve obtained with calibrators that have been analyzed on the same microplate.
Here's a breakdown of the acceptance criteria and study details for the Sebia FLC Kappa and FLC Lambda kits, based on the provided FDA 510(k) summary.
Note: This document describes an in vitro diagnostic (IVD) device, which measures specific analytes (free light chains) in human serum using a laboratory assay (ELISA). The concepts of "AI assistance," "human readers," "radiologist," and "image" are not relevant to this type of device. Therefore, sections pertaining to these concepts (like MRMC studies) are not applicable and will be marked as such. The "ground truth" for an IVD kit is established through various analytical performance studies demonstrating its accuracy and reliability compared to established methods, and clinical studies correlating its results with disease states.
Acceptance Criteria and Device Performance for Sebia FLC Kappa and FLC Lambda Kits
1. Table of Acceptance Criteria & Reported Device Performance
The FDA 510(k) summary does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds. Instead, it details various performance studies and their results, which implicitly form the basis for acceptance. The reported device performance is indicated by the successful execution of these studies and the obtained values meeting recognized clinical laboratory standards (e.g., CLSI guidelines).
General Performance Categories and Key Findings:
| Performance Category | Acceptance Criteria (Implicit from CLSI Guidelines/Industry Norms) | Reported Device Performance (Key Findings) |
|---|---|---|
| Precision (Reproducibility) | Low Coefficient of Variation (CV%) across various conditions (within-run, between-runs, within-day, between-days, operators, lots, sites). Generally, CV% should be within acceptable limits for diagnostic assays. | FLC Kappa: Total %CVs for single-site, multi-operator, multi-lot, and multi-site reproducibility studies were generally below 15% across various sample concentrations, which is typical for acceptable immunoassay precision. |
| FLC Lambda: Similar to Kappa, total %CVs across various reproducibility studies were generally below 15%, demonstrating acceptable precision. (e.g., Multi-site total reproducibility: 11.4% to 15.2%) | ||
| Linearity/Assay Range | Demonstrated linearity across the claimed analytical measuring range, with slopes near 1 and intercepts near 0 for linear regression. | FLC Kappa: Linear between 4.5 mg/L and 76.2 mg/L. Three panels showed linear regressions with slopes close to 1 (e.g., Y=1.009x -0.2967, Y=1.016x -0.2014, Y=0.9332x + 0.4952) and small Y-intercepts. |
| FLC Lambda: Linear between 3.8 mg/L and 66.8 mg/L. Three panels showed linear regressions with slopes close to 1 (e.g., Y=1.046x -1.537, Y=0.9561x -0.62, Y=0.9611x -0.31) and small Y-intercepts. | ||
| Limits (LOB, LOD, LOQ) | Limits of Blank (LOB), Detection (LOD), and Quantitation (LOQ) must be established and clinically relevant. LOQ typically related to imprecision (e.g., |
§ 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).