There are many misconceptions in the clinical industry regarding laboratory quality control materials. With numerous products available and manufacturers using various labeling practices, how do you know what’s best for your laboratory?
To help clear up the confusion, we’re answering two important questions clinical laboratorians have about quality control products.
Are diagnostic system controls IVDs?
One common misconception is that materials used for quality control of diagnostic systems are not themselves in vitro diagnostics (IVDs). However, the U.S. Food & Drug Administration (FDA) has written regulations citing quality control material as medical devices. For example, 21 CFR 862.1660, Mulit-Analyte Controls Unassayed under Clinical Chemistry, and more recently 21 CFR 866.3920, classify Class II controls requiring FDA 510(k) review under microbiology.
It’s important to understand that if a manufacturer for controls of nucleic acid amplification states its product works with a specific instrument or assay in its labeling or marketing literature, the FDA considers the material to be a Class II IVD and requires a 510(k) review. The FDA has established special controls for this type of material to ensure the product is properly labeled, performs according to claims and remains stable. In addition, IVD material must be manufactured under the FDA’s current Good Manufacturing Practices (cGMP).
Should “Research Use Only” products be used for quality control?
The second misconception clinical laboratories should be aware of involves material labeled as Research Use Only (RUO). RUO labeling is intended for products that are still under development and are not commercially distributed. A developer would use this labeling to ship product for “investigation relating to product development” as explained by the FDA in guidance document, Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigation Use Only.
Another factor one must consider is products labeled RUO are not required to be manufactured in accordance with cGMP and FDA Quality System Regulation. Lack of manufacturing controls may be detrimental to the quality of the control material. As such, clinical laboratories using RUO quality control materials to ensure the quality of testing may be placing patients at unnecessary risk.
To maintain the highest possible quality of your diagnostic testing, it’s best to choose materials that have been manufactured by a cGMP compliant facility under the FDA QSR, and when necessary reviewed by the FDA. Materials clearly labeled as IVDs provide that assurance and lower your laboratory’s risk.
Follow the links below to find all the FDA regulations cited in this post.
- 21 CFR 862.1660 CFR – Code of Federal Regulations Title 21, Subchapter H – Medical Devices
- 21 CFR 866.3920 CFR – Code of Federal Regulations Title 21, Subchapter H – Medical Devices
- Distribution of In Vitro Diagnostic Products Labeled for Research Use Only of Investigation Use Only
Tina Sobania, M.S., is the Director of Corporate Quality at Microbiologics where she leads the Quality Systems and Technical Support departments. Tina has over 20 years of medical device quality system and regulatory experience. She earned her bachelor’s degree in manufacturing engineering from St. Cloud State University and holds a Master of Science from the University of St. Thomas.