LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

The LensHooke X3 PRO and X3 PRO SE Semen Quality Analyzers are optical devices that automatically analyze human semen samples to measure sperm concentration, motility (progressive, non-progressive, and immotility), morphology, and pH value. The X3 PRO is intended for point-of-care professional settings in clinical laboratories, while the X3 PRO SE is a self-testing system for over-the-counter home use. Neither device provides comprehensive fertility evaluation.

Both subject devices use the same desktop architecture as the predicate: light sources, built-in video microscopy, and internal computer algorithms for semen parameter assessment. The key difference is the transmission interface—the X3 PRO adds Ethernet capability (HDMI/USB/Ethernet) compared to the predicate's HDMI/USB only. The X3 series is compatible with the new CS1 Semen Test Cassette and includes the X QC Video control material for motility and morphology assessment, whereas the predicate used CS0/CS1 and only X QC Beads/Reticle.

Not stated in this summary.

The subject devices measure identical semen parameters (concentration, motility categories, morphology, pH) and do not provide comprehensive fertility assessment, matching the predicate's intended use and clinical significance. Both use the same underlying optical and algorithmic technology for image capture and analysis. Although the X3 adds Ethernet connectivity and new QC video material, these are minor enhancements that do not alter the fundamental technology or clinical performance. The user performance study demonstrated that lay users can obtain accurate results equivalent to point-of-care professionals using the predicate, establishing functional parity despite the expansion to over-the-counter use for the SE variant.