FDA-Compliant Blood Glucose Monitor Studies
Blood glucose monitoring devices are subject to some of the most detailed FDA accuracy requirements in the noninvasive device space. At Vital Signs Research Group, we conduct glucometer testing and glucometer validation studies at our San Francisco clinical research facility, helping manufacturers of blood glucose monitors build the clinical evidence required for FDA 510(k) clearance.
From traditional fingerstick glucometers to continuous glucose monitoring (CGM) adjacent devices, we design clinical studies tailored to your device’s intended use, target population, and regulatory pathway.
Our glucometer validation studies are conducted in alignment with FDA guidance on blood glucose monitors and applicable ISO 15197 accuracy standards for non-significant risk devices. Each study is reviewed and approved by our external IRB (Advarra) and conducted in full compliance with ISO 14155, FDA 21 CFR 50, and FDA 21 CFR 812.
We recruit study participants from our pre-screened database, including individuals across a range of glucose levels and demographics to meet FDA requirements for a representative study population. Our team of registered nurses and clinical research coordinators ensures precise protocol execution and complete data integrity throughout every study day.
Our glucometer testing process includes accuracy testing across the clinically relevant glucose range, reference measurement pairing with laboratory-grade comparator methods, diverse participant recruitment meeting regulatory distribution requirements, full study documentation, and a clinical report formatted for FDA submission. (confirm with client: specific glucose range tested and reference method used — e.g., YSI or laboratory hexokinase method)
Whether you’re a startup seeking your first FDA clearance or an established manufacturer validating a next-generation device, we’ll build a glucometer validation study that meets the mark.
Contact Vital Signs Research Group to start your glucometer testing study — precision matters, and we bring it to every study we run.