PULSE OXIMETRY

At PRL, we test pulse oximeter performance through controlled desaturation studies that adhere to ISO 80601-2-61 and FDA guidance. Our protocols are designed to reduce SpO₂ levels from 100% down to 70%, using gold-standard co-oximetry to evaluate device accuracy. In support of development studies that do not require arterial lines, we can utilize a well-characterized reference pulse oximeter transfer standard. 

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A core focus of our methodology is ensuring equitable performance across skin pigmentations, which is achieved through deliberate recruitment from a diverse participant population representing the full Monk Skin Tone Scale and ITA values. This inclusive, data-rich approach provides manufacturers with the robust, submission-ready evidence needed for regulatory success.

Our studies are executed by a dedicated, multidisciplinary team of physicians, nurses, and researchers operating under strict GCP and participant safety protocols. Arterial lines are placed exclusively by our full-time Principal Investigator, a board-certified anesthesiologist, ensuring the highest level of clinical precision and oversight. Our team is skilled in arterial blood sampling and co-oximetry, enabling accurate, real-time validation across all saturation levels. Thanks to this clinical expertise and thoughtful protocol design, we achieve high participant completion rates even at lower saturation targets, with over 90% of participants tolerating desaturations below 80% SaO₂ and 100% below 85% SaO₂.

With low screen failure and withdrawal rates, and a large, actively managed participant database, PRL ensures rapid, demographically balanced enrollment and consistently high-quality outcomes.