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IMMULITE® PSA Control Module Device intended as an aid in monitoring the DPC's and performance of of IMMULITE IMMULITE 2000 PSA assays.
IMMULITE PSA Control Module is an assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring dayto-day assay performance.

Quality Control Material

The provided text is a 510(k) summary for the IMMULITE® PSA Control Module, a quality control material. It does not contain information about acceptance criteria or a study proving performance for a device intended for clinical diagnosis in the way a typical AI/ML device would.

The document states:

• Device Name: IMMULITE® PSA Control Module
• Intended Use: An assayed, tri-level control intended for use with the IMMULITE PSA and IMMULITE 2000 PSA assays. It is intended as an aid in monitoring day-to-day assay performance.
• Clinical Studies: "Not applicable"

Therefore, I cannot extract the specific information requested in your numbered list for an AI/ML device's performance study because the document is about a quality control material, not a diagnostic device that requires such performance criteria and studies. The "study" mentioned is the FDA's review of the 510(k) submission to establish substantial equivalence to a predicate device, not a clinical trial demonstrating diagnostic accuracy.

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