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The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).

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Here's the information about the acceptance criteria and the study for the InstaRead™ Lithium System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain specific acceptance criteria for performance metrics (like accuracy, precision, or comparison to a predicate device). It primarily focuses on the regulatory approval for marketing.

However, based on the context of a "Lithium test system," typical acceptance criteria would involve demonstrating equivalency to a legally marketed predicate device in terms of:

• Accuracy/Correlation: How well the device's measurements correlate with a reference method or predicate device.
• Precision/Reproducibility: The consistency of results when the same sample is tested multiple times.
• Linearity/Range: The ability of the device to accurately measure lithium across its claimed analytical range.

Since these specific criteria and their actual performance values are not detailed in the provided FDA letter, the table below reflects what would typically be expected in such a submission, but with "Not Specified" for the actual values. The document states a "substantial equivalence determination," implying these criteria were met.

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