Team-NB publishes position paper on Combinatorial Use of Reagent Devices

Team NB published a new position paper on Combinatorial Use of Reagent Devices. The position paper is intended to clarify notified body expectations concerning demonstration of safety and performance of reagents used with other equipment.

The position paper covers reagents that are categorized as “closed systems” (defined combinations) or “open systems” (compatible with general lab equipment).

The position paper includes definitions of closed and open systems:

• closed system or defined combination;

  • e.g., reagent is only compatible with one specific instrument;

  • e.g., reagent can be used on different, but specified, instruments and/or accessories;

• open system;

  • e.g., reagent can be use on similar general lab equipment/instruments.

For “closed systems,” manufacturers are required to conduct a full performance evaluation for at least one combination. Other combinations would require demonstrated equivalence.

For “open systems,” manufacturers are required to define and justify critical equipment specifications in the Instructions for Use.

The position paper also highlights that manufacturers bear full responsibility for the safety and performance of the entire combinatorial workflow.