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 skilled in arterial line placement, arterial blood sampling, and co-oximetry, all under strict GCP and participant safety protocols. 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.