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The IMMULITE/IMMULITE 1000 Total Testosterone is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

The IMMULITE 2000 Total Testosterone is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

IMMULITE/IMMULITE 1000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for use with the IMMULITE and IMMULITE 1000 Analyzers.

IMMULITE 2000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for use with the IMMULITE 2000 Analyzer.

The provided text describes diagnostic devices for measuring testosterone, but it does not contain information about acceptance criteria or specific studies demonstrating how the device meets such criteria.

The document is a 510(k) summary for the IMMULITE®/IMMULITE® 1000 Total Testosterone and IMMULITE® 2000 Total Testosterone devices, aiming to demonstrate substantial equivalence to previously cleared predicate devices. While it describes the technology (solid-phase, competitive chemiluminescent immunoassay) and intended use, it does not include performance data, clinical study results, or specific acceptance criteria for precision, accuracy, sensitivity, or other performance characteristics that would typically be part of a study proving a device meets acceptance criteria.

The "Conclusion" section explicitly states: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE/IMMULITE 1000 Total Testosterone and IMMULITE 2000 Total Testosterone." This implies that the full data set, which would include performance studies and their results against acceptance criteria, was submitted to the FDA separately and is not part of this public 510(k) Summary.

Therefore, I cannot provide the requested information from the provided text.

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