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QC-Beads TM are intended for use as controls in counting sperm manually using a microscope or automatically using computer assisted semen analysis instruments.

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This document is a 510(k) premarket notification acceptance letter for the QC-Beads™ device, a hematology quality control mixture. It does not contain information about acceptance criteria, device performance, study details (like sample sizes, data provenance, expert qualifications, adjudication methods), or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The regulatory classification of the device.
• General controls and requirements under the Federal Food, Drug, and Cosmetic Act.
• The intended use of the device: "QC-Beads™ are intended for use as controls in counting sperm manually using a microscope or automatically using computer assisted semen analysis instruments."

To answer the user's request, a different document, such as the actual 510(k) submission or a performance study report, would be needed.

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