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This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer™ II. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer™ II. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.

This kit is intended for the quantitation of kappa free light chains in serum and urine on the Beckman Coulter IMMAGE™. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Beckman Coulter IMMAGE™. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.

This kit is intended for the quantitation of kappa free light chains in serum and urine on the Hitachi 911/912/917/Modular P. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Hitachi 911/912/917/Modular P. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.

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This document is a 510(k) premarket notification from the FDA, specifically concerning various versions of the FREELITE™ Human Kappa and Lambda Free Light Chain kits for use on different nephelometer systems.

The document states the indications for use for these kits, which define their intended purpose in clinical diagnosis and monitoring. However, it does not contain information regarding acceptance criteria for device performance, or any studies undertaken to prove the device meets such criteria.

Therefore, I cannot provide a detailed response to the following points based solely on the provided text, as this information is not present:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is primarily an FDA clearance letter indicating that the agency has determined the device to be substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. It does not include the detailed study results or performance data that would typically be part of a 510(k) submission itself.

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