scope:

This guidance document provides information on the establishment and verification of shelf-life and in-use stability claims for quantitative and qualitative in vitro diagnostic (IVD) reagents. It includes background information and typical content to consider when creating a stability testing plan for a particular product, logistics of performing the studies, recommended data analyses, and documentation of stability claims. Additional topics include assessment of product transport conditions on stability claims, stability monitoring (verification), and uses of accelerated stability testing.

The intended users of this guideline are primarily manufacturers of IVD reagents and regulatory agencies. Clinical laboratorians may find this information useful in interpreting commercial product stability claims, as well as for establishing stability attributes of "laboratory-developed test" methods.

This guideline does not address instrument systems, laboratory equipment, software, or patient samples. Stability testing of raw materials or components of reagent kits or consumables is not addressed explicitly. The principles described in this document could, however, be adapted by manufacturers toward that purpose.