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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 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.

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 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,

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 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 devices in this submission have not materially changed since clearance under K171742. The purpose for this submission is to add monitoring of multiple myeloma (MM) to the intended use.

Here's a breakdown of the requested information based on the provided text, focusing on the expanded indication for monitoring Multiple Myeloma (MM) with the N Latex FLC kappa and N Latex FLC lambda assays:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document beyond the performance metrics themselves. However, the study aims to demonstrate substantial equivalence to the predicate device and satisfactory agreement with clinical status for MM monitoring. The reported performance is as follows:

Note: The document states "For the predicate device similar data were obtained when compared to clinical status," suggesting the 26% sensitivity for progression is considered acceptable in this context given the device's role as an "aid" in diagnosis and monitoring.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Clinical Status Comparison: 391 patients (divided into 47 with Progression and 344 with No Progression).
  • Agreement with Clinical Assessment: 391 patients.
  • Comparison to Predicates (Response Category): 391 patients.
  • Comparison to Predicates (Follow-up Graphs): 102 patients.
• Data Provenance: The study was a "multi-center study." The country of origin is not explicitly stated, but the submission is from Siemens Healthcare Diagnostics Products GmbH, based in Germany. The study appears to be retrospective as it compares results with existing clinical assessments and predicate device results.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing the ground truth. It mentions "clinical assessment provided by the physician in charge within the Case Report Form (CRF)."

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. "Clinical assessment provided by the physician in charge" suggests a singular clinical judgment rather than a consensus or adjudicated process among multiple experts for the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic assay, not an imaging AI system that would typically involve human readers.

6. Standalone Performance

Yes, a standalone performance analysis was done. The N Latex FLC assays were evaluated independently in comparison to clinical status and then compared to the predicate devices. The sensitivity and specificity values are derived from the algorithm's performance in categorizing patient status.

7. Type of Ground Truth Used

The ground truth used was clinical assessment based on IMWG FLC criteria, taking into account IFE (immunofixation electrophoresis) and serum FLC measurements in conjunction with "other clinical findings" and "further information in addition to serum testing" as provided by the treating physician in the Case Report Form.

8. Sample Size for the Training Set

The document does not mention a training set. This is a diagnostic assay, and the study focuses on evaluating its performance (validation) rather than training an algorithm. The "training set" concept is more applicable to machine learning-based AI devices.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set is described for this device.

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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.

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