Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?
Open accessAbstract
Recently, the Food and Drug Administration (FDA) published guidance documents for point-of-care testing (POCT) and over-the-counter (OTC) blood glucose monitoring systems (BGMS). These are expected to improve weaknesses of the already established ISO 15197:2013 standard accuracy evaluation for OTC BGMS; however, the proposed criteria and procedures rather raise new questions. As an example, the OTC guidance stipulates tighter accuracy criteria in the low glycemic range than the POCT guidance for no obvious reason. Furthermore, a clear definition of requirements for the reference method is missing under consideration of the strict accuracy criteria. External surveillance of BGMS after introduction to the market is an issue that is addressed neither in the FDA documents, nor in ISO 15197, but in the Clinical and Laboratory Standards Institute (CLSI) guideline POCT12-A3.
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Procedures might be used that exhibit variations between devices, reagent system, or calibrator batches.
“Therefore, reference measurement procedures from different manufacturers, as well as, for example, comparison measurement procedures used in independent postmarket evaluations may provide systematically different results, 21 or procedures might be used that exhibit variations between devices, reagent system, or calibrator batches.22-24”
From Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems (2022) · cites this paper as [23]
The “Measurement of Reference Values” section (page not supplied) reports measurement differences between devices of the same model. The “Testing Procedures” section requires testing three reagent-system lots, but does not say those lots produce different results; our copy also does not establish variation between calibrator batches. (LLM, conf=0.86)
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- Authors
- Freckmann, G., Baumstark, A., & Pleus, S.
- Affiliations
- Universität Ulm (DE)
- Corresponding author
- Freckmann, Guido
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2017-06-06
- Volume
- 11
- Issue
- 6
- Pages
- 1240-1246
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC5951049
- OpenAlex
- W2622212158
- Cited by
- 13
- References
- 9
- Citations by year
- 2024: 1 · 2021: 3 · 2020: 3 · 2019: 1 · 2018: 5
- FWCI
- 1.82
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- blood glucose monitoring systems, FDA guidance, ISO 15197, point-of-care testing, accuracy assessment, diabetes mellitus
- MeSH terms
- Blood Glucose, Documentation, Humans, Predictive Value of Tests, Time Factors, United States, United States Food and Drug Administration, Blood Glucose Self-Monitoring, Reproducibility of Results, Biomarkers, Practice Guidelines as Topic, Monitoring, Ambulatory, Device Approval
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