Quick facts
- A multipurpose system for in vitro coagulation studies is a Class II device in the United States at 21 CFR 864.5425.
- Canada regulates a coagulation analyser as an in vitro diagnostic device. Used in patient management it reaches Class II through Rule 3 of Part 2 of the Medical Devices Regulations.
- The same analyser used outside a laboratory, at the point of care, is a near patient IVDD and is Class III under Rule 6.
- Where an analyser is used with reagents that carry a higher class, Rule 7 gives both the class of the higher-risk device.
- A coagulation result that guides a decision in a life-threatening situation can push the device to Class III under Rule 3(b).
- The regulation text quoted here is current to 2026-09-21 and was last amended on 2026-06-17.
A coagulation analyser measures how long blood takes to clot, or how much of a clotting factor is present. It is used to monitor anticoagulant therapy, to screen for a bleeding disorder, and to check a patient before surgery. The same box of electronics can sit in a central laboratory or on a ward bench, and that single fact changes its Canadian class.
What is a coagulation analyser?
It is an instrument that measures a clotting endpoint in a blood sample. Some analysers detect the change in light or in movement when fibrin forms; others use a mechanical or magnetic endpoint. The instrument runs a reagent with the sample and reports a time in seconds or a derived ratio.
The analyser is an in vitro diagnostic device. It examines a specimen taken from the body, and it does so outside the body. That is what places it in Part 2 of the Canadian rulebook rather than Part 1, and it is why the class turns on how the result is used rather than on what the instrument is made of.
How do Canada and the United States classify a coagulation analyser?
The instrument is Class II in the United States, and in Canada its class moves with where it is used and what the result decides.
| Item | Canada | United States |
|---|---|---|
| Coagulation analyser, laboratory | Class II by Part 2 Rule 3 | Class II, 21 CFR 864.5425 |
| Same analyser at point of care | Class III by Part 2 Rule 6 | Depends on the entry and use |
| Analyser used with higher-class reagents | Class of the higher-risk device, Rule 7 | Accessory to the named entry |
| Basis named in the rulebook | Rule and intended use | Device entry and product code (JPA) |
| What decides the class | Where and how the result is used | Which named entry it is filed under |
In the United States a multipurpose system for in vitro coagulation studies is a named entry at 21 CFR 864.5425 and is Class II. In Canada no Part 1 rule names a coagulation analyser, because it is an IVDD. Rule 3 of Part 2 classifies an IVDD intended for patient management as Class II, unless it is used in the management of patients with a life-threatening disease or an erroneous result would lead to a management decision causing an imminent life-threatening situation, in which case it is Class III.
The line that catches most suppliers is Rule 6. A near patient IVDD is classified as Class III. The definition covers a device intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional's office or the bedside. The identical analyser that is Class II on a laboratory bench is Class III on the ward.
Which licence and records differ between Canada and the United States?
The class decides the depth of the application, and the depth is not the same for a laboratory instrument and a bedside instrument.
In the United States a Class II device is placed on the market through the premarket notification route, and the manufacturer keeps the design, labelling and performance records that entry requires. In Canada a Class II IVDD needs a medical device licence supported by a quality-system certificate against ISO 13485, while a Class III IVDD carries a heavier application with a review of the performance evidence for the device. The instruments are the same; the file is not.
That is the trap in a point-of-care deployment. A hospital that moves an analyser from the laboratory to a ward bench, or a supplier that markets the same instrument for a clinic room, has moved the device into the near patient definition. The class, and the licence that follows from it, changes with the location the manufacturer intends.
Why does the same analyser carry two classes in Canada?
Because Part 2 of the Canadian rulebook grades an IVDD by where it is used and what an erroneous result could cause.
Rule 3 sets the base class at II for an IVDD used in patient management, then steps up to Class III where the device manages a life-threatening disease or where a wrong result would lead to a management decision causing an imminent life-threatening situation. Rule 4 covers an IVDD used in diagnosis that is not caught by Rules 1 to 3, and also sets Class II with its own step-ups for cancer, genetic testing and related uses. Rule 7 is the pairing rule: where an IVDD, including its analysers, reagents and software, is intended to be used with another IVDD, both take the class of the higher-risk device. Rule 8 is the fallback, placing all other IVDDs in Class I.
Rule 6 is the one that shapes the deployment decision. It states that a near patient IVDD is classified as Class III, and the definition of near patient is fixed in the interpretation section: use outside a laboratory, for testing at home or at the point of care. Nothing about the analyser changes when it is wheeled from one room to another, but the Canadian class does.
Which consumables does a coagulation bench restock?
A coagulation bench runs on the same items as any other laboratory station. The sterile graduated 90 mL specimen cups and the 120 mL sterile screw-cap container carry samples to and from the bench. Where the laboratory monitors its own steriliser, the sterilization monitoring collection pairs with the 24-hour monitoring five-pack trial. Laboratories and multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
What do the two rulebooks actually say?
The two texts are short, and reading them side by side locates the line that moves a laboratory analyser into a higher class.
| Rule or entry | Verbatim wording | Effect on a coagulation analyser |
|---|---|---|
| Part 2 Rule 3, Canada | intended to be used for patient management is classified as Class II | Sets the laboratory base class at II |
| Part 2 Rule 6, Canada | A near patient IVDD is classified as Class III | Moves a point-of-care analyser to Class III |
| Part 2 Rule 7, Canada | the class of both IVDDs will be that of the IVDD in the class representing the higher risk | Raises the analyser with its reagents |
| 21 CFR 864.5425, US | System, multipurpose for in vitro coagulation studies | Named Class II entry |
| Rule 8, Canada | all other IVDDs are classified as Class I | Applies only where no higher rule is engaged |
Read together, the lines give a supplier a sequence of questions. Is the result used for patient management? Is the device used outside a laboratory? Do its reagents carry a higher class? The first answer sets Class II; the second lifts it to Class III; the third lifts it with the pairing device.
Sources
- 21 CFR 864.5425, multipurpose system for in vitro coagulation studies
- 21 CFR 864.5220, automated differential cell counter
- 21 CFR 864.7500, whole blood hemoglobin determination
- 21 CFR 864.6160, diluting pipette
- 21 CFR 862.1660, quality control material
- Medical Devices Regulations, SOR/98-282, full text
- openFDA device classification API
- ISO 15189:2022, medical laboratories, requirements for quality and competence
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management for medical devices
- CLSI, clinical and laboratory standards
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- Government of Canada, medical devices guidance
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- American Academy of Ophthalmology, eye health
- Canadian Dental Association
- Royal College of Dental Surgeons of Ontario
- Standards Council of Canada
A coagulation result that is not tied to its reagent lot cannot be defended when a value is questioned. The printable coagulation run log is a blank sheet with columns for the run date, the analyser, the reagent lot, the control result and the patient result, so a suspect run is found from the page rather than from the memory. The run record generator on the same page sizes the sheet to the number of analysers a laboratory runs. No account and no sign-up are needed to open either one.
Every laboratory layout is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Anticoagulation Clinic Orders: Cost per INR Test
- Blood Glucose Test Systems in Canada vs the US: Which Class Applies?
- Laboratory Centrifuges in Canada vs the US: Which Class Applies?
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is a coagulation analyser a Class II device in the United States?
Yes. A multipurpose system for in vitro coagulation studies is a named Class II entry at 21 CFR 864.5425, filed under product code JPA.
How does Canada classify the same analyser in a laboratory?
Canada regulates it as an in vitro diagnostic device. Used in patient management it reaches Class II through Rule 3 of Part 2 of the Medical Devices Regulations.
What makes the class move to Class III in Canada?
Use outside a laboratory. A near patient IVDD, defined as testing at home or at the point of care, is classified as Class III under Rule 6.
Does the reagent change the class?
It can. Rule 7 gives an analyser and the IVDD it is used with the class of the higher-risk device, so reagents that carry a higher class lift the analyser with them.
Can a life-threatening use push the device up?
Yes. Rule 3(b) steps a patient-management IVDD up to Class III where a wrong result would lead to a management decision causing an imminent life-threatening situation.
What does the class change for a supplier?
A Class II IVDD sold in Canada needs a licence supported by a quality-system certificate against ISO 13485, and a Class III device carries a heavier application with review of the performance evidence.
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