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510(k) Data Aggregation
(267 days)
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
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.
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(626 days)
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
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., |
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