(267 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 and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.
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 and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.
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.
The provided document is an FDA 510(k) clearance letter and associated summary for the Sebia FLC Kappa and FLC Lambda kits. These kits are in vitro diagnostic (IVD) devices used for quantifying free light chains in human serum. They are immunoassay-based tests, not AI/ML-driven devices.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device cannot be extracted from this document. The concepts of "test set," "training set," "experts to establish ground truth," "adjudication methods," "MRMC studies," and "standalone performance" are relevant to AI/ML device evaluations, but they do not apply to the traditional IVD assay described here.
The document discusses analytical and clinical studies for the immunoassay, focusing on performance characteristics such as:
- Clinical Study: Evaluates the concordance of FLC Kappa and FLC Lambda kit results with clinical assessment and other tests for monitoring Multiple Myeloma and AL Amyloidosis.
- Sample size:
- Multiple Myeloma: 551 follow-up samples from 235 unique subjects.
- AL-amyloidosis: 190 follow-up samples from 87 unique subjects.
- Data Provenance: Subjects had "expanded racial and ethnic diversity (Caucasian, African American, Hispanic, Asian)". No specific country of origin is mentioned, but the manufacturer is based in France and the submission is to the US FDA. The studies appear to be retrospective analyses of follow-up samples.
- Ground Truth: Clinical assessment and other tests based on criteria from the IMWG (International Myeloma Working Group) for Multiple Myeloma and consensus guidelines (Comenzo et al., 2012; Palladini et al., 2012; Kumar et al., 2022 NCCN guidelines) for AL-Amyloidosis.
- No mention of experts establishing ground truth or adjudication methods in the context of human readers for an AI system, as this is a laboratory assay.
- No MRMC study, as this is not an image-based or AI-assisted diagnostic.
- No separate "standalone" algorithm performance because the device itself is the diagnostic assay.
- No specific training set or how its ground truth was established is mentioned, as this is a traditional laboratory assay, not a machine learning model.
- Sample size:
- Stability Studies: Determined shelf-life for the kits and controls.
In summary, this document describes a traditional immunoassay, not an AI/ML device. Thus, the requested AI/ML-specific information is not applicable and not present.
§ 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).