For IVD performance evaluation only (test tube with a question mark)

The standard’s wording, as the sources below reproduce it:

“Indicates an IVD medical device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use.”

ISO 15223-1:2021, 5.5.6 · ISO 7000-3083

What it means for you

This test kit is a pre-market sample for studies of how well it performs. Its results are not to be used to diagnose or treat anyone.

Whether a device is right for you is a question for your pharmacist, nurse or doctor.

What it looks like: A test tube, partly filled, with a question mark above its mouth.
Where you see it: Laboratory reagents and test kits supplied to clinical study sites before they are CE-marked or cleared.
Other names: performance evaluation; not for diagnostic use; evaluation kit

What it does not tell you

It does not say the test is inaccurate, only that it has not been placed on the market for diagnostic use.

Often confused with

In vitro diagnostic medical device (IVD)ISO 15223-1:2021, 5.5.1

Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.

More symbols in “Tubes, lines and valves”

Sterile fluid pathISO 15223-1:2021, 5.2.9 Fluid path (square bracket)ISO 15223-1:2021, 5.6.2 Non-pyrogenic (crossed wavy lines)ISO 15223-1:2021, 5.6.3 One-way valve (bow tie with an arrow)ISO 15223-1:2021, 5.6.6

Sources

ISO 15223-1 is a paid standard, so the wording above is quoted as 2 publishers’ public documents reproduce it. Each was fetched and read on the date shown:

NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the test tube with a question mark for reference no. 5.5.6 (ISO 7000-3083): “Indicates an IVD device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use.” Checked 2026-09-28.
Stago: Glossary of symbols (520233-A_EN) — “For IVD performance evaluation only — Indicates an IVD medical device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use.” NF EN ISO 15223-1, symbol #5.5.6. Checked 2026-09-28.

Plain-language parts are in our own words; quotations are the sources’ wording.