Laboratory Centrifuges in Canada vs the US: Which Class Applies?

Quick facts

• A bench centrifuge is an active device: it depends for its operation on a source of energy other than energy generated by the human body or gravity.
• Canada names centrifugation in a rule. Rule 6 of Schedule 1 to the Medical Devices Regulations, SOR/98-282 reaches non-invasive devices that modify the biological or chemical composition of blood or other body fluids for introduction into the body; Rule 6(3) then states that a device which accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is Class II.
• The United States splits centrifuges by purpose. A microsedimentation centrifuge is Class I; a hematocrit measuring device, which the section describes as a system of instruments, tubes, racks, a sealer and a holder used to measure packed red cell volume, is Class II with special controls.
• The practical consequence is that the same bench unit can be Class I or Class II in the United States depending on the claim on its label, while Canada's outcome depends on whether the unit is doing the modifying step.
• A centrifuge that never touches the sample — a rotor and lid that only spin sealed tubes — is reached differently from a system that opens, seals or reads the sample.

A centrifuge is one of the few laboratory instruments that both processes a specimen and, in some configurations, measures it. That dual role is why the classification question is not as simple as "it is a machine". Both countries have rules that turn on what the unit does to the sample, but they place the hinge in different spots, and the difference is worth understanding before a laboratory buys, replaces or registers a unit.

What counts as a laboratory centrifuge for classification purposes?

Three configurations behave differently under both systems.

• A general bench centrifuge. A rotor, a lid and a speed control. The sample stays inside a sealed tube that the operator loads and removes.
• A microcentrifuge. A small high-speed unit for microfuge tubes, used for pelleting and phase separation at the bench.
• A dedicated system. A unit that is part of a measurement, such as a haematocrit system that includes the tubes, the racks, the sealer and the holder, or a blood bank or cell-washing centrifuge that is validated for a specific preparation step.

The third configuration is where the classification diverges most, because it is the configuration where the unit stops being a machine and becomes part of a test. The haematocrit measuring device entry in the United States is exactly that: the section describes a system that measures packed red cell volume, produced by centrifuging a given volume of blood, and classifies it as Class II with special controls, exempt from premarket notification subject to the limitations in 21 CFR 864.9.

How do the Canadian rules reach a centrifuge?

Canada reaches a centrifuge through the classification rules rather than through a catalogue of instrument names, and Rule 6 is the rule that matters most.

Rule 6(1) covers a non-invasive device intended for modifying the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration, and classifies it as Class III. Rule 6(2) adds that where the modification process may introduce a potentially hazardous foreign substance, the device is Class IV. Rule 6(3) then does something unusual: it states that a device described in subrule (1) that accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is classified as Class II.

Read together, Rule 6 ranks the modification method. Removing or exchanging material mechanically is treated as the lower-risk route, and a centrifuge that performs that step is pulled down from Class III to Class II. A centrifuge that does not perform the modification step at all is not reached by Rule 6: a bench unit used to pellet cells in a sealed tube, where the tube contents are not intended for introduction into the body, falls to Rule 12 as another active device and is Class I.

Item	Canada	United States
Bench centrifuge, general use	Rule 12, Class I	No named entry for a general centrifuge
Microcentrifuge at the bench	Rule 12, Class I	Grouped with the purpose-specific entries by label claim
Microsedimentation centrifuge	Rule 12 Class I unless Rule 6 applies	21 CFR 864.5350, Class I
Haematocrit measuring system	Rule 6(3) Class II where it performs the modifying step	21 CFR 864.6400, Class II with special controls
Blood bank centrifuge	Rule 6(3) Class II where it modifies blood for transfusion use	Class I entry for blood bank use for in vitro diagnostic use
Cell-washing system	Rule 6(3) Class II	Class II entry for automated cell washing for immuno-haematology
Drive for the class	Whether the unit performs the modifying step	The labelled purpose of the unit

Which rule decides the class, and why does the answer keep changing?

The answer changes because the wording of the rules is tied to purpose, and purpose is a function of the label and the standard operating procedure rather than of the hardware.

In Canada the chain runs like this:

• Is the device active? A centrifuge is, because it depends on an external energy source.
• Does it modify the composition of blood or another body fluid for introduction into the body? If yes, Rule 6 applies, and Rule 6(3) puts it in Class II.
• If not, Rule 12 catches it as any other active device and it is Class I.
• Two add-ons can raise the class regardless of the base rule: Rule 7(2)(a) raises a device that calibrates, tests or supports quality control of another device to Class II, and Rule 7(2)(b) raises a device intended to be connected to an active device classified Class II, III or IV to Class II.

In the United States the chain runs through the classification database instead. The unit is matched to a device name, the name carries a regulation number, and the regulation number states the class and the exemption. That is why a haematocrit system lands in Class II while a microsedimentation centrifuge lands in Class I: they are described as different devices, not as different machines.

Worked through by bench task, the divergence looks like this:

Task at the bench	Canada	United States
Pelleting cells in sealed tubes	Rule 12 Class I	No named entry for the general bench unit
Separating serum for chemistry	Rule 12 Class I unless Rule 6 applies	21 CFR 864.5350 Class I where the label describes microsedimentation
Measuring packed cell volume	Rule 6(3) Class II where the unit performs the modifying step	21 CFR 864.6400 Class II with special controls
Preparing blood for transfusion use	Rule 6(3) Class II	Class I entry for blood bank in vitro diagnostic use
Washing cells for immuno-haematology	Rule 6(3) Class II	Class II entry for automated cell washing
Supporting a Class II analyser	Rule 7(2)(b) Class II if connected to it	Software and accessories follow the parent device

What should a laboratory be able to show for a centrifuge?

Five items, and the first is the one that decides everything else.

• The intended use on the label. The labelled purpose is the class driver in the United States and the trigger for Canadian rules such as Rule 6(3).
• Whether the unit performs a modifying step. A unit that only spins sealed tubes is reached differently from a system that seals and reads the sample.
• The rotor and tube compatibility record. Rotor and tube combinations belong in the equipment file because the tube must survive the speed it is spun at.
• The service and calibration record. Where a unit is used to support a test, the record of its performance check belongs with the test method.
• The incident record. A tube failure is an exposure incident and an equipment failure at the same time, and both records should point at each other.

Which consumables does a specimen bench use?

A specimen bench restocks tubes, specimen containers, transport bags and personal protective equipment in the same cycle as its instruments. For laboratories 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. The sterile 15 mL centrifuge tubes are the consumable that matches this instrument, the graduated leak-proof specimen containers cover bench collection, and laboratories that also run an in-house sterilizer can start with the biological indicator 5-pack trial and the sterilization monitoring collection.

Sources

1. 21 CFR 864.6400, hematocrit measuring device
2. 21 CFR 864.5350, microsedimentation centrifuge
3. 21 CFR 864.9, limitations of exemptions
4. 21 CFR 862.2050, general purpose laboratory equipment
5. 21 CFR 864.3260, automated blood cell counter
6. Medical Devices Regulations, SOR/98-282, full text and Schedule 1
7. Health Canada, medical devices
8. openFDA device classification API
9. FDA device classification database
10. CLSI standards
11. ISO 15189:2022, medical laboratories, requirements for quality and competence
12. ISO 8655-2:2022, piston-operated volumetric apparatus
13. Public Health Ontario, laboratory test information index
14. Public Health Ontario, infectious diseases
15. Canadian Centre for Occupational Health and Safety, OSH answers
16. CCOHS, personal protective equipment
17. World Health Organization, laboratory biosafety manual
18. US OSHA bloodborne pathogens standard, 1910.1030
19. Institute for Quality Management in Healthcare
20. College of Medical Laboratory Technologists of Ontario

Related reading

• Microcentrifuge Tubes in Canada vs the US: Which Standards and Labelling Apply
• Falcon Tubes in Canada vs the US: Which Conical Tube Specs Apply
• Laboratory Water Baths in Canada vs the US: Which Rules Apply
• Laboratory Glassware in Canada vs the US: Which Standards Apply

CliniEco Medical supplies eye care, laboratory and clinic consumables of the kind described in this article. MDEL #35334. This article is written for clinic, procurement and infection-control professionals and is not clinical guidance; instrument qualification and method validation belong to the laboratory director and the quality manager.

Frequently Asked Questions

Is a laboratory centrifuge a Class I or Class II device in Canada?

It depends on what the unit does. A centrifuge that performs the modifying step on blood or another body fluid intended for introduction into the body is reached by Rule 6(3) of Schedule 1 to the Medical Devices Regulations, which classifies a device that accomplishes the modification by centrifugation as Class II. A bench centrifuge that only spins sealed tubes is reached by Rule 12 and is Class I.

Why does Rule 6(3) matter so much?

Because it is the one clause in the Canadian classification rules that names a processing method. Rule 6(1) puts a device that modifies the biological or chemical composition of blood or body fluids for introduction into the body in Class III, and Rule 6(3) then lowers a device that achieves the modification by centrifugation, gravity filtration or the exchange of gas or heat to Class II.

Are all centrifuges Class I in the United States?

No. A microsedimentation centrifuge is Class I under 21 CFR 864.5350, but a hematocrit measuring device is Class II with special controls under 21 CFR 864.6400, and there are Class II entries for automated cell washing and for blood bank use. The class follows the device description in the section, not the word centrifuge.

What is a hematocrit measuring device in the CFR?

The section describes it as a system consisting of instruments, tubes, racks, a sealer and a holder, used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. It is classified Class II with special controls and is exempt from premarket notification subject to 21 CFR 864.9.

Does the rotor or the tube affect the device class?

No. Rotor and tube compatibility is an equipment safety and performance question, and the record of it belongs in the equipment file. The class follows the intended use of the device as a whole.

What record should follow a centrifuge in a clinical laboratory?

The labelled intended use, the rotor and tube compatibility record, the service and performance-check record, and the incident record where a tube has failed. Where the centrifuge supports a specific test, the performance check belongs with that method rather than only with the equipment inventory.