Quick facts
- United States: a quality control material for clinical chemistry is reached through 21 CFR 862.1660, which is written for "assayed and unassayed" controls and classifies the device as Class I.
- United States: the same section states that the device "may be used for proficiency testing in interlaboratory surveys" and names controls for blood gases, electrolytes, enzymes, multianalytes, single analytes and urinalysis.
- United States: 21 CFR 862.1660 exempts the material from premarket notification "except when intended for use in donor screening tests", and an assayed control material for clinical microbiology is reached through 21 CFR 866.3920 as Class II.
- Canada: an in vitro diagnostic device takes the rules in Part 2 of Schedule 1 to the Medical Devices Regulations, SOR/98-282, and a control material carries no named entry of its own.
- Both countries: a material used to estimate test precision is a device in its own right, separate from the analyser and the reagent it is used with.
- Canada: regulation text cited here is current to 2026-10-03; the American entries were last amended 65 FR 2308, January 14, 2000 and 84 FR 71796, December 30, 2019.
Every analytical run sits on a control. The control is not a reagent and it is not a calibrator — it is a sample of known value that is run beside the patient samples to show that the system is behaving. A laboratory that treats it as a consumable rather than as a device tends to be the one whose records cannot show why a run was accepted. The two countries reach the same material by two different routes.
What does a control material have to do to count as a device?
It has to be intended to estimate precision, and the American definition says so in one sentence.
21 CFR 862.1660 describes the device as one "intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation". That wording sets the boundary. A material that is run to check precision is a control material. A material used to assign a value to a patient sample is a calibrator, and a material used to dilute is a diluent, and the three sit in different places.
The section then lists the assay families the material covers. Controls for blood gases, electrolytes, enzymes, multianalytes, single analytes and urinalysis are named. That list is the reason a single quality control section can sit under a chemistry panel, a blood gas analyser and a urine bench at once.
| Control type | American section | Class | Note |
|---|---|---|---|
| Assayed chemistry control | 21 CFR 862.1660 | Class I | Value is stated by the maker |
| Unassayed chemistry control | 21 CFR 862.1660 | Class I | Value is established in house |
| Blood gas control | 21 CFR 862.1660 | Class I | Named in the section |
| Urinalysis control | 21 CFR 862.1660 | Class I | Named in the section |
| Assayed microbiology control | 21 CFR 866.3920 | Class II | Separate microbiology entry |
Does the American exemption apply to every control material?
No, and the exception is the one a laboratory should note first.
The classification sentence in 21 CFR 862.1660 reads that the material is Class I and, with one carve-out, is "exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9". The carve-out is a material "intended for use in donor screening tests". A control used beside a donor screening assay does not carry the exemption, and a laboratory that groups all its controls under one policy will miss that.
The second limit is that the exemption sits on the chemistry entry. An assayed control material for clinical microbiology is reached through a different section, 21 CFR 866.3920, which classifies the material as Class II. A laboratory order that mixes a chemistry control and a microbiology control is ordering across two classes.
How does Canada reach a control material without a named entry?
Through the general rules for an in vitro diagnostic device, and the class follows the intended use rather than the material.
Schedule 1 to the Medical Devices Regulations, SOR/98-282 sets the classes. A control material is a device used in an examination of a specimen taken from the body, so it sits in the in vitro diagnostic family and takes the rules in Part 2 of the Schedule. There is no section that names a control material, so the class is reached by applying the rules to what the material is for.
That is the difference a laboratory feels when it writes a device list. On the American side the list can cite a section that names the material and states a class. On the Canadian side the list states the intended use and the rule that was applied, with the section of the Schedule that carries it. ISO 15189:2022 is the laboratory quality standard that sits over both lists, and ISO 17511:2020 is the standard that governs the traceability of the values assigned to calibrators and trueness control materials.
| Item | Canada | United States |
|---|---|---|
| Named entry for a control material | None in Schedule 1 | 21 CFR 862.1660 and 866.3920 |
| Route to the class | Part 2 rules applied to the intended use | The section states the class |
| Chemistry control class | Reached by the Part 2 rules | Class I |
| Microbiology control class | Reached by the Part 2 rules | Class II |
| Donor screening control | No exemption of the American kind | Exemption does not apply |
What does a laboratory record for a control run?
Six fields, and the two that are most often missing are the lot and the acceptance rule.
- The control material and its lot. A control lot change moves the target, so the lot belongs on the run record rather than on the packing slip only.
- The level. A low, normal and high control are three different checks, and a run made on one level is a different statement from a run made on three.
- The acceptance rule. The rule that decides whether a run is accepted is written before the run, not after.
- The instrument and the reagent lot. A shift can come from either, and the record is what separates them.
- The action taken on a rejection. A rejected run that is repeated needs the reason the repeat was accepted.
- The reference. The section or rule that gives the class of the material, with the currency date of the text used.
Which consumables does a control bench restock?
A control bench runs on the containers and swabs that carry a specimen away from it. The sterile graduated specimen cups hold the primary sample, the 120 mL sterile screw-cap containers hold a larger volume, and a laboratory that runs its own steriliser pairs the sterilization monitoring collection with the biological indicator 5-pack trial. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
A run record built on those fields answers a proficiency survey and an audit from the same page, which is the whole reason the control is run in the first place. The Public Health Ontario laboratory services index is where the specimen and testing pathway for an Ontario laboratory begins.
Sources
- 21 CFR 862.1660, quality control material (assayed and unassayed)
- 21 CFR 866.3920, assayed quality control material for clinical microbiology
- Medical Devices Regulations, SOR/98-282
- Health Canada, drug and health product portal
- ISO 15189:2022, medical laboratories requirements
- ISO 17511:2020, metrological traceability of values
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- ISO 15197:2013, systems for blood glucose monitoring
- ISO 11133:2014, culture media preparation
- Public Health Ontario, laboratory services test index
- Public Health Ontario, specimen acceptance criteria
- CCOHS, OSH answers
- World Health Organization, tuberculosis
- openFDA device classification API
- College of Medical Laboratory Technologists of Ontario
- Canadian Society for Medical Laboratory Science
- Clinical and Laboratory Standards Institute
- Canadian Paediatric Society, clinical documents
- World Health Organization, antimicrobial resistance
A control run that cannot show its own record is a run that has to be repeated. The printable quality control run sheet is a free sheet with columns for the control lot, the level, the acceptance rule and the action taken, so a rejected run is written down while it is still open. The run sheet generator built around a single bench sizes the sheet to the number of analytes and control levels a laboratory runs. No account and no sign-up are needed to open either one.
Where the class of a control material or the record expected for a run needs to be set out for an inspection, a written answer is worth more than a general one. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Blood Culture Bottles in Canada vs the US: Which Rules Apply
- Automated Urinalysis Systems in Canada vs the US: Which Class Applies
- Laboratory Centrifuges in Canada vs the US: Which Class Applies
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for laboratory, quality and procurement professionals and is not legal advice; the control materials used and the records kept by a laboratory belong to the laboratory's quality system and to the requirements that apply to it.
Frequently Asked Questions
What makes a material a quality control material rather than a calibrator?
A quality control material is run to estimate the precision of a test system and to detect a systematic deviation. A calibrator is used to assign or check the value a system reports, so the two are separate device types with separate entries.
What class is a quality control material in the United States?
A quality control material for clinical chemistry is Class I under 21 CFR 862.1660. An assayed control material for clinical microbiology is Class II under 21 CFR 866.3920.
Does the United States exempt quality control materials from premarket notification?
The chemistry entry exempts the material from premarket notification except when it is intended for use in donor screening tests. A control used beside a donor screening assay does not carry that exemption.
How does Canada classify a quality control material?
Schedule 1 to the Medical Devices Regulations names no control material, so the class is reached by applying the Part 2 rules to the intended use of the device.
Which standard covers the traceability of a control material value?
ISO 17511:2020 covers the requirements for establishing the metrological traceability of values assigned to calibrators, trueness control materials and human samples.
Which records should a control run keep?
Record the control material and lot, the level, the acceptance rule, the instrument and reagent lot, the action taken on a rejection, and the section or rule that gives the class of the material.
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