Grouping medical devices as an IVD Test Kit

Reagents or articles with the same product owner that are meant to be used in combination for specific intended purpose. They are sold under a single test kit name or labelled for use with the IVD test kit.

IVD Test Kit grouping requirements

An IVD Test Kit is an in vitro diagnostic (IVD) device that consists of reagents or articles that are:

  • From the same product owner.
  • Intended to be used in combination for a specific purpose.
  • Compatible when used as a test kit.
  • Sold under a single test kit name or the labeling for each reagent or article states that the component is intended for use with the IVD test kit.

An IVD Test Kit and its accompanying analyser can be listed together on the SMDR as an IVD system or the analyser can be listed separately from the IVD test kit.

Note: An IVD Test Kit does not include the instruments, such as analysers, needed to perform the test.

IVD Test Kit reagents and articles

Individual reagents or articles can be supplied separately as replacement items for the kit.

IVD Test Kit Product registration

Reagents or articles that are supplied for use in more than one test kit

To include in the product registration of each test kit

Reagents or articles from another product owner

Reagents and articles may be grouped together in an IVD Test Kit if all information required for registration, such as the following is provided:

  • Authorisation from the other product owners for registration.
  • Data to support the performance of these reagents when used in the test kit.

For example, a Human Immunodeficiency Virus (HIV) Enzyme Linked ImmunoSorbent Assay (ELISA) test kit may contain controls, calibrators and washing buffers. All the reagents and articles are used together to detect HIV and can be grouped as a test kit. These reagents and articles can be supplied separately as replacement items for that particular Test Kit.