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The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined mu heavy and k light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.

The Optilite Hevylite IgM Lambda Kit is intended for the quantitative in vitro measurement of IgM lambda (combined u heavy and a light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.

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I apologize, but the provided text content does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for two in vitro diagnostic kits (Optilite Hevylite IgM Kappa Kit and Optilite Hevylite IgM Lambda Kit) and describes their intended use.

Specifically, the document states:

• Trade/Device Name: Optilite® Hevylite® IgM Kappa Kit, Optilite® Hevylite® IgM Lambda Kit
• Regulation Number: 21 CFR § 866.5510
• Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system
• Regulatory Class: II
• Product Code: PDE, PDF
• Indications for Use: Quantitative in vitro measurement of IgM kappa or IgM lambda in serum using the Binding Site Optilite analyser, to be used with previously diagnosed Waldenström's macroglobulinaemia, and in conjunction with other laboratory and clinical findings.
• Limitation: "This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia."

The letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. However, it does not provide details about the specific studies conducted, acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your detailed questions.

To get this information, you would typically need to refer to the full 510(k) submission summary or other supporting documentation for these devices, which is not provided in the given text.

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