Specimen

The specimen types an IVD is validated for are part of its intended purpose. Using the test on another specimen type, such as saliva instead of serum, needs its own performance evidence.

Is a discrete portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole. This also includes other materials, for example, hair, nails excretions, secretions, or a sample from the skin surface.

MDCG 2022-2, Section 4, Definitions (source: MDCG IVD classification guidance)

is a discrete portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole. This also includes other materials, for example, hair, nails excretions, secretions, or a sample from the skin surface.

MDCG 2020-16 Rev.5, Section 2, Definitions

Any discrete portion of a body fluid or tissue taken for examination, study, or analysis of one or more quantities or characteristics to determine the character of the whole body fluid or tissue. See ISO 20916 section 3.47.

MDCG 2024-4, Section 4.19

Small portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole.

MDCG 2022-3 Rev.1, Section 3, Definitions (3.7)

The discrete portion of a body fluid or tissue taken for examination, study, or analysis of one or more quantities or characteristics.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary

The core wording is shared across the texts. MDCG 2022-2 and MDCG 2020-16 extend it to other materials such as hair and nails, while the other definitions refer only to body fluid or tissue.