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Diazyme Colorimetric Lithium Assay kit is for quantitative in vitro determination of lithium in human serum or EDTA plasma. Measurements of lithium are carried out to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.

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This document is an FDA 510(k) clearance letter for the Diazyme Colorimetric Lithium Assay. It formally grants permission to market the device based on a determination of substantial equivalence to predicate devices. However, this document does not contain the detailed study information regarding acceptance criteria and performance data.

The letter primarily covers:

• Confirmation of 510(k) review and clearance.
• The trade/device name, regulation number/name, regulatory class, and product code.
• General controls and additional regulations applicable to the device (e.g., Quality System regulation, UDI rule, MDR).
• Contact information for FDA resources.
• The "Indications for Use" statement for the device.

To answer your specific questions, one would typically need access to the 510(k) submission document itself, specifically the performance data sections. The provided FDA letter is the clearance notice, not the supporting technical file.

Therefore, I cannot provide the information requested in your prompt based solely on the provided FDA clearance letter. The letter confirms that a review was done and clearance granted, implying that the device did meet acceptance criteria demonstrated in the submission, but it does not detail those criteria or the study results.

To answer your questions, I would need a different document, such as the actual 510(k) application's test report or a summary of safety and effectiveness data (SSE) that outlines the performance studies.

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