(25 days)
QC-Beads TM are intended for use as controls in counting sperm manually using a microscope or automatically using computer assisted semen analysis instruments.
Not Found
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.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.