Quick facts
- United States: a system that measures blood gases and blood pH is a named entry — 21 CFR 862.1120, blood gases and blood pH test system — and sits in Class II.
- United States: the entry is filed under product codes for electrode measurement of blood gases, including CHL, and the class does not change with where the instrument is used.
- Canada: a blood gas analyser is an in vitro diagnostic device, and the class comes from the rules in Part 2 of the classification schedule rather than from a named entry.
- Canada: a near patient IVDD is defined as one intended for use outside a laboratory, at home or at the point of care, and Rule 6 classifies a near patient IVDD as Class III.
- Canada: the short table in Rule 9 lowers a near patient device only for pregnancy or fertility testing and for cholesterol, so a near patient blood gas analyser is not lowered and stays in Class III.
- Canada: the regulation text cited here is current to 2026-09-21 and was last amended on 2026-06-17.
A blood gas result is read the same way in both countries, but the two systems behind the analyser do not treat it the same way. One fixes a class to the instrument by name; the other decides a class from where the instrument is used. For a clinic or a hospital buyer, that split decides what a near-patient unit has to carry and what a bench unit is allowed to assume.
What does a blood gas analyser measure?
It measures the partial pressures of carbon dioxide and oxygen in blood and the blood pH, and it does that from a small whole-blood sample.
The instrument is a diagnostic analyser. A sample is drawn into a heparinised collection device, taken to the analyser, and read by electrodes in contact with the sample. The result drives decisions about ventilation and acid-base balance, which is why the reading is used at the bedside as often as it is used in a laboratory.
That clinical role is what the classification turns on. A blood gas result informs patient management, and in Canada patient management is one of the uses the in vitro diagnostic rules name directly.
| Item | Canada | United States |
|---|---|---|
| How the analyser is described | By rule, as an IVDD | A named entry at 21 CFR 862.1120 |
| Class for a laboratory bench unit | Class II under the patient-management rule | Class II |
| Class for a near-patient unit | Class III under Rule 6 | Class II |
| What a filing cites | The rule and its subrule | The device entry and product code |
What does the American entry cover for blood gases?
It names the system and fixes the class, and the class does not move with the setting.
21 CFR 862.1120 describes a system that measures the partial pressures of carbon dioxide and oxygen and the pH of blood. The entry sits in Class II, and the instruments that fall under it are filed with product codes such as CHL for electrode measurement of blood gases. A unit on a laboratory bench and a unit in a critical care bay are, for classification purposes, the same device.
What this means for a buyer is that the American class is a statement about the instrument, not about the room. The room decides the workflow and the consumables; the entry decides the class.
How are blood gas analysers classified in Canada?
They are classified as in vitro diagnostic devices under Part 2 of the schedule, and the class is reached from the use rather than from the name.
An analyser intended for diagnosis or patient management is placed in Class II by the patient-management rule, and it moves to Class III where an erroneous result could lead to a management decision that creates an imminent life-threatening situation. The general diagnostic rule does the same for a device used in diagnosis, with the higher class applying where an error could cause death or severe disability or where the device is used for cancer screening, genetic testing, fetal screening or disease staging.
The critical piece for blood gases is the near patient rule. A near patient IVDD is defined in the regulations as one 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. Rule 6 classifies a near patient IVDD as Class III, and the exceptions in the short table that follows cover only pregnancy or fertility testing and cholesterol. Blood gases are not on that list.
| Use of the analyser | Canadian rule | Canadian class | US entry and class |
|---|---|---|---|
| Laboratory bench analysis | Patient management, Part 2 Rule 3 | Class II | 862.1120, Class II |
| Point-of-care or bedside analysis | Near patient IVDD, Part 2 Rule 6 | Class III | 862.1120, Class II |
| Analysis where an error is immediately dangerous | Part 2 Rule 3, imminent risk | Class III | 862.1120, Class II |
Does a near-patient blood gas analyser change class in Canada but not the United States?
It does. The same analyser that is Class II on a laboratory bench becomes Class III at the point of care in Canada, while the American entry keeps it in Class II wherever it sits.
This is the point most often missed when a clinic buys a point-of-care unit on the strength of a bench instrument it already owns. The two are the same instrument; they are not the same classification when the Canadian near patient rule applies. A buyer who orders the second unit on the first unit's paperwork has carried the wrong class across.
The practical consequence is that the intended use has to be written down before the order is placed. A unit bought for the laboratory bench and a unit bought for the bedside should carry their intended use on the purchase record, because in Canada that field is what the class is read from.
How do the patient-management rules differ between Canada and the United States?
The American rules fix a class to the device entry; the Canadian rules fix a class to the use. That single difference explains why the same analyser can be Class II in one country and Class III in the other.
In the United States, a system matching the blood gas entry is Class II because that is the class the entry carries. There is no subrule inside the entry that escalates on the setting. In Canada, the analyser is read against patient management, diagnosis and the near patient rule, and the highest applicable class is the one that applies.
A buyer comparing two quotations therefore has to compare two different kinds of statement. An American quotation is describing an instrument; a Canadian quotation is describing the use the instrument is sold for, and the two should be checked against each other rather than against a single label.
Which consumables does a blood gas bench restock?
A blood gas bench runs on the collection and handling lines that sit beside the analyser. The graduated specimen cups cover the sample handling step, and the 120 mL sterile screw-cap container carries a specimen that has to be held. For a laboratory that also runs its own sterilisation cycle, the sterilization monitoring collection pairs with the 24-hour monitoring five-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.
Sources
- 21 CFR 862.1120, blood gases and blood pH test system
- 21 CFR 862.1660, quality control material (assayed and unassayed)
- 21 CFR 862.2160, discrete photometric chemistry analyzer
- 21 CFR 864.7500, whole blood hemoglobin assays
- 21 CFR 866.2900, microbiological specimen collection and transport device
- Medical Devices Regulations, SOR/98-282
- ISO 15189:2022, medical laboratories
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- IEC 61010-1:2010, safety of electrical measuring equipment
- ISO 15197:2013, blood glucose monitoring systems
- openFDA device classification API
- CLSI, clinical and laboratory standards
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- American Academy of Ophthalmology, dry eye
- Ad Standards, non-prescription and cosmetic guidelines
- Canadian Dental Association
A bench whose sample-handling record is missing is a bench that cannot answer a question about the last run. The printable blood gas bench log is a free sheet with columns for the analyser, the control run, the operator and the date, so a quality-control record is written down rather than remembered. The bench log generator built for a single analyser sizes the sheet to the number of analysers a laboratory runs. No account and no sign-up are needed to open either one.
Ordering blood gas consumables for a hospital lab or a clinic? See the wholesale ordering page.
Related reading
- 95 kPa Bags vs Rigid Containers for Sample Transport
- Stage Micrometers in Canada vs the US: Which Device Class
- Inoculating Loops in Canada vs the US: Which Type and Standard
CliniEco Medical supplies laboratory, eye care 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 an analyser and the records kept by a laboratory belong to the laboratory and to the requirements that apply to it.
Frequently Asked Questions
Is a blood gas analyser a Class II device in the United States?
Yes. A system measuring the partial pressures of carbon dioxide and oxygen and the pH of blood matches the entry at 21 CFR 862.1120, which sits in Class II, and the class does not change with where the instrument is used.
What is a near patient IVDD in Canada?
It is an in vitro diagnostic 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.
Why is a near patient blood gas analyser Class III in Canada?
Rule 6 classifies a near patient IVDD as Class III, and the exceptions in the short table cover only pregnancy or fertility testing and cholesterol. Blood gases are not on that list, so the near patient class stays at Class III.
Can the same analyser be Class II and Class III in Canada?
Yes. The same instrument on a laboratory bench is Class II under the patient-management rule, and at the point of care it is Class III under the near patient rule. The intended use is what separates the two.
Does the American class change at the point of care?
No. The entry at 21 CFR 862.1120 stays in Class II wherever the analyser is used, so a bench unit and a bedside unit share the same class in the United States.
What sample container sits beside a blood gas analyser?
A heparinised collection device is used for the blood gas sample itself, and a graduated specimen cup or a screw-cap container covers the handling steps around it, with the container's cap and label carrying the identification a laboratory needs.
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