SQA-iOw Sperm Quality Analyzer

The SQA-iOw Sperm Quality Analyzer is an automated in-vitro diagnostic device that analyzes human semen samples to measure sperm concentration, motile sperm concentration, progressively motile sperm concentration, and normal morphology percentage. It is intended for CLIA-waived settings and provides derived parameters including total motility, progressive motility, non-progressive motility, and immotility percentages. The device does not provide comprehensive fertility status evaluation.

The SQA-iOw uses a desktop unit with light source and optical sensors connected to a PC running cloud-based software containing proprietary algorithms, whereas the predicate SQA-V contained a built-in video microscopy system and internal computer. Both devices use the same SQA-V testing capillary, perform the same semen parameter measurements, and employ QwikCheck Beads for quality control. The key difference is the SQA-iOw is designed for CLIA-waived users while the predicate required trained technicians in CLIA moderate/high complexity settings.

The nonclinical testing references CLSI EP05-A3 standard for precision studies. Clinical precision studies used ANOVA analysis and Passing-Bablok regression analysis with 95% confidence intervals to compare results between waived users and trained operators.

The SQA-iOw is substantially equivalent to the SQA-V predicate because both devices measure the same semen parameters using electro-optical technology on identical sample types for male fertility assessment. The method comparison study of 380 native semen samples showed high correlation coefficients (0.96–1.0) between waived-user SQA-iOw results and trained-operator SQA-V results across all parameters, with slopes and intercepts indicating excellent agreement. Precision studies demonstrated acceptable repeatability and reproducibility across multiple sites and operators, meeting established criteria for all measured and derived parameters.