(158 days)
N Latex FLC kappa and lambda assays: In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL).
N FLC Supplementary Reagent: Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA).
N FLC Standard SL: Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems.
N FLC Controls SL1 and SL2: The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems.
The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® Systems. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). Used in conjunction with the assay reagents, N FLC Standard SL is for use in the establishment of reference curves for the determination of free light chains, type kappa and type lambda on the BN™ II and BN ProSpec® Systems. The N FLC Control SL 1 and 2 products are for use as assayed accuracy controls and precision controls in the determination of free light chains, type kappa and type lambda by immunonephelometry with the BN™ II and BN ProSpec® Systems. The FLC test systems are based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with monoclonal antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated when mixed with samples containing FLC. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
The provided text describes the Siemens N Latex FLC kappa and N Latex FLC lambda assays, along with their associated calibrators and controls. These devices are intended for the quantitative determination of free light chains (FLC) in human serum and EDTA plasma, used as an aid in diagnosing multiple myeloma (MM) and amyloidosis (AL).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the performance characteristics presented in the study. For analytical performance, typical acceptance limits for precision (CV%), linearity, and interference are industry standards for IVD devices. For clinical performance, the reported sensitivity and specificity values against clinical diagnosis are the acceptance metrics.
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Standard) | Reported Device Performance and Remarks |
|---|---|---|---|
| Analytical Performance | Precision (Total CV%) | Typically |
§ 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).