N Latex FLC kappa, N Latex FLC lambda

K190879 · Siemens Healthcare Diagnostics Products GmbH · DFH · May 3, 2019 · Immunology

Device Facts

• Record ID: K190879
• Device Name: N Latex FLC kappa, N Latex FLC lambda
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: DFH · Immunology
• Decision Date: May 3, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Indications for Use

In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and as an aid in the diagnosis of amyloidosis (AL) in conjunction with other laboratory and clinical findings. The response category assignment of 'Complete Response' for the monitoring of MM, is reliant upon the combination of clinical history and other tests including protein electrophoresis, immunofixation and bone marrow, imaging and urine assessments.

Device Story

N Latex FLC assays are in-vitro diagnostic reagents for quantitative determination of free light chains (FLC) in human serum and EDTA-plasma. Input samples are processed via particle-enhanced immunoassay on Atellica CH or BN systems. Polystyrene particles coated with monoclonal antibodies agglutinate with FLC in samples; agglutination increases turbidity/light scattering. Device measures change in absorbance (turbidimetry) or light scattering (nephelometry) proportional to protein concentration. Results are compared against known standards to quantify FLC levels. Used in clinical laboratories by trained personnel. Output assists physicians in diagnosing and monitoring multiple myeloma and amyloidosis. Clinical utility relies on integration with patient history, protein electrophoresis, immunofixation, bone marrow, imaging, and urine assessments. Supplementary reagents suppress interference from rheumatoid factors and HAMA.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements to confirm performance on the Atellica CH Analyzer platform.

Technological Characteristics

Particle-enhanced immunoassay using polystyrene particles coated with monoclonal mouse anti-human FLC antibodies. Detection via turbidimetry (Atellica CH) or nephelometry (BN Systems). Quantitative measurement in mg/L. Reagents include supplementary mixture to suppress rheumatoid factor and HAMA interference. Calibration interval 42 days.

Indications for Use

Indicated for the quantitative determination of free light chains (kappa and lambda) in human serum or plasma on the Atellica CH Analyzer.

Regulatory Classification

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.

Predicate Devices

• N Latex FLC kappa (K182098)
• N Latex FLC lambda (K182098)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: K190879

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device.

K182098, N Latex FLC kappa
N Latex FLC lambda

2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the previously cleared N Latex FLC kappa and lambda assays on the Atellica CH Analyzer.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, and physical characteristics has provided.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.