Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Short answer: glucose control solution is a liquid with a known glucose level that you apply to a test strip in place of blood, to check that the meter and strips are working together properly. It is a quality check on the test system, not a test of a person’s blood sugar. Who uses it: people who use blood glucose meters, and clinic or point-of-care staff who manage meters and strips.
What glucose control solution is
The U.S. Food and Drug Administration (FDA) states that a blood glucose test system “works with liquid control solutions to ensure the test is operating normally.” FDA’s guidance for over-the-counter self-monitoring systems adds the purpose: external control solutions let users periodically check that the meter and test strips are working together properly and that the device is performing correctly.
It is a separate consumable from the meter and from the strips. Pair it with the system it is labeled for: the manufacturer’s instructions for use (IFU) name which meter and strips a control solution is intended for, and those instructions govern how and when to run a test.
What a control test does and does not tell you
A control test answers one question: are this meter and this strip working together correctly, and is the test being performed correctly? One manufacturer insert describes it in just those terms, and says to refer to the owner’s booklet for how and when to run it. A control test does not measure glucose in a person, and it is not a substitute for the accuracy testing manufacturers do before a device is cleared.
That accuracy testing is a separate thing. FDA’s guidance for over-the-counter systems describes criteria of 95% of results within ±15% and 99% within ±20% of a comparator method across the claimed measuring range. The guidance also says manufacturers often base validation on the ISO 15197 standard, but that FDA believes the ISO 15197 criteria are not sufficient to adequately protect lay users, citing concerns such as results in the hypoglycemic range and variation across strip lots. These are premarket device criteria; they are not something a control solution test checks at home or in a clinic.
How the system is built
A control solution is used as one part of a three-part system: the meter, the test strip and the control material. FDA’s guidance says a submission should describe how the device distinguishes control material from patient specimens, whether automatically or manually, so that control results are not mixed up with patient results. Check the meter’s IFU to see how your system handles this.
FDA also advises that at least two levels of control material should be specified in the labeling as available to the user.
Why control solutions are numbered, not low, normal or high
FDA’s guidance says control solutions should be labeled non-descriptively, for example numerically as 1, 2, 3, rather than as “low”, “normal” or “high”. The reason given is that users may read “normal” as meaning a clinically normal glucose level. A control level is a reference value for checking equipment and says nothing about anyone’s health.
Types and variants
| Item | What FDA states |
|---|---|
| Levels | At least two levels of control material should be specified in the labeling as available to the user (FDA guidance, section VI.F). |
| Level names | Labeled non-descriptively, for example numerically (1, 2, 3), not low, normal or high (FDA guidance). |
| Use by the user | Use of external control solutions by the user should be promoted (FDA guidance). |
| Control versus patient sample | The device should distinguish control material from patient specimens, automatically or manually (FDA guidance). |
When a control test is used
FDA’s consumer page suggests running a control solution test every time you open a new container of test strips. A manufacturer insert also says that if you keep getting unexpected results, you should check the system with control solution. Beyond these two points, the exact schedule is set by the manufacturer’s IFU for your meter and strips, and facilities set their own quality-control schedules; follow the insert and your facility’s procedure.
Safe use and handling basics
- Apply only control solution or a blood sample to the test strip, as one manufacturer insert states. Do not use a strip again after control solution has been applied to it; see glucose blood test strips.
- FDA notes that improperly stored meters and test strips may give less accurate results. Store the meter, strips and control solution as the IFU directs.
- Do not rely on a figure from another product. Expiry, discard-after-opening time and the acceptable result range for a control are stated in the control solution’s own insert and are specific to the product and strip lot; use the values in your insert.
Common mistakes
- Treating a control result as a patient result. Control material is for checking the system only.
- Reading a control level name as a health category. Levels are numbered for this reason.
- Using a control solution not labeled for the meter and strips in use.
- Assuming a control test replaces a manufacturer’s accuracy claims, or that it validates ISO 15197 compliance. It does neither.
Frequently asked questions
What is glucose control solution used for?
To check that a blood glucose meter and its test strips are working together properly and that the test is being performed correctly (FDA).
How often should you run a control test?
FDA suggests a test every time you open a new container of test strips. Follow your meter’s IFU for any further schedule.
Does it replace the meter’s accuracy testing?
No. Accuracy criteria are premarket device criteria set out in FDA guidance; a control test checks a system in use.
Related guides and supplies
See what a glucometer is, point-of-care testing and the diabetes clinic supply checklist. Clinics stocking meters and related consumables can browse diagnostic, monitoring and imaging supplies.
Sources
- U.S. Food and Drug Administration, Blood Glucose Monitoring Devices (content current as of 11/14/2024; checked 2026-10-30).
- U.S. Food and Drug Administration, Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, guidance issued September 29, 2020 (checked 2026-10-30).
- LifeScan, OneTouch Ultra test strip insert, one example manufacturer instructions for use (checked 2026-10-30).
