Quick facts
- A cell-freezing apparatus is the instrument that cools cells at a controlled rate so that they can be stored and later recovered, and it is used with the reagents and the containers the maker specifies.
- United States: the apparatus and its reagents are reached as a cell-freezing apparatus for in vitro diagnostic use at 21 CFR 864.9225, placed in Class I; the openFDA classification API lists it under product code KSP.
- Canada: the apparatus is part of an in vitro diagnostic device system, and where no earlier rule catches it, it reaches Class I through Rule 8 of Part 2 to Schedule 1 of the Medical Devices Regulations, SOR/98-282.
- At the container level the cryogenic vial that holds the cells follows the same IVD path, so the apparatus, the reagent and the vial are ordered as a system rather than as unrelated items.
- The two countries land on the same class: Class I in the United States and Class I in Canada, by different machinery.
- The entry and rule text below were checked against the current CFR text and the Regulations on 2026-10-08.
A cell-freezing apparatus is the instrument a laboratory uses when a living sample has to survive the trip into a freezer and back. It controls the rate of cooling, because a sample cooled too quickly forms ice that ruptures the cells, and it works with the reagent and the container the maker specifies. It is filed as a device in both countries, and it is the container rather than the console that a laboratory most often gets wrong. This article sets out what the apparatus does, how each country files it, and what a laboratory should be able to point at when the instrument is bought and when the vial is filled.
What does a cell-freezing apparatus do?
The apparatus cools a sample at a controlled rate, often around one degree a minute, so that water leaves the cell before it freezes inside it. Some instruments do this in a passive chamber with an alcohol bath, and some do it in a programmable freezer that follows a curve. Either way, the rate, the final temperature and the thaw are the three steps that decide how many cells recover.
The apparatus is used with the reagent that protects the cells and the container that holds them, and the three are designed as a system. A vial that is not rated for the freezing step, or a reagent used at the wrong concentration, changes the recovery whether or not the console was set correctly.
How does the United States file a cell-freezing apparatus?
In the United States the apparatus is reached by a named entry. 21 CFR 864.9225 covers a cell-freezing apparatus and reagents for in vitro diagnostic use, and the section places it in Class I. The openFDA classification API lists it under product code KSP at Class I. A Class I device of this kind is subject to general controls.
The entry names the apparatus and reagents together, which is why a laboratory that changes the reagent without checking the section is changing part of a system the entry treats as one article. The container the cells are frozen in belongs to the same order of questions.
Why does Canada reach Class I as an IVDD?
Canada does not keep a named entry for the apparatus. A reagent or instrument used to examine a specimen taken from the body is an in vitro diagnostic device, and the Rules in Part 2 to Schedule 1 classify it. Rules 1 to 7 reach IVDDs that detect a transmissible agent, that are used for patient management, or that are near-patient devices. A general cell-freezing apparatus is not caught by those rules, so Rule 8 applies: every other IVDD is classified as Class I.
The part a laboratory should read carefully is Rule 7, which deals with an IVDD used with another IVDD: the class of both follows the device in the higher class. If the apparatus is used with a higher-class IVD, the apparatus is drawn up with it. That is why the intended use of the whole system, not of the console alone, is the fact that decides the class.
| Item | Canada | United States |
|---|---|---|
| Named entry | No entry names the apparatus; it is an IVD | 21 CFR 864.9225 |
| Class | Class I by Rule 8; the IVD it is used with may lift it under Rule 7 | Class I |
| Basis of the class | The IVDD rule that catches the device | The named entry the apparatus is filed under |
| Product code | Not applicable | KSP |
| Premarket route | Establishment licence; a Class I IVDD does not get a licence of its own | General controls |
| Reagent basis | The reagent follows the same IVD path | The reagent is named in the same entry |
| Container basis | The vial follows the maker's instructions for the system | The vial follows the maker's instructions for the system |
The two countries agree that the apparatus is a low-risk article; they disagree only on whether it is named or reached by rule. A laboratory that keeps the system's intended use on file has the document that decides which Canadian rule applies.
Which standards sit behind the apparatus?
The class says how the apparatus is regulated; the standards say how it has to behave. ISO 13485:2016 is the quality management basis behind the manufacturer's records, and ISO 14971:2019 is the risk management basis behind the design file. A laboratory that asks for those two documents is asking for the evidence behind the recovery the apparatus claims.
| Element | What it covers | Why it matters in the cryobank |
|---|---|---|
| Cooling rate | How fast the sample is cooled | A rate that is too fast ruptures cells as the ice forms |
| Final temperature | The temperature the sample settles at | A sample that is not cold enough does not store |
| Thaw step | How the sample is brought back | A thaw that is too slow harms the cells that survived the freeze |
| Reagent | The protective solution used | A reagent off its stated concentration changes recovery |
| Vial rating | The container the cells are frozen in | A vial not rated for the step is a loss, not a result |
| Records | The freeze run and the vial identity | The link between a run and the sample stored |
An apparatus that cannot show its last validation and a vial that cannot be traced to a run are the two gaps that meet in the same freezer.
How is a freeze run validated?
A freeze run is validated against the curve the maker specifies rather than against a single temperature. The rate, the hold and the thaw are recorded for the run, and the record is reconciled with the position and the identity of the vial that was frozen in it. A run held without a curve cannot be compared with the maker's claim, and a vial held without a run cannot be traced to the freeze it came from.
The validation is repeated when the apparatus, the reagent or the container changes, because the three are a system. A laboratory that swaps one for another without re-running the validation is changing a part of the system the entry names together, and the recovery the apparatus claims is a claim about all three.
What else sits beside the apparatus?
The cryobank is stocked as a system. Sterile centrifuge tubes, 50 mL sit with the sample-prep lines, and a graduated leak-proof specimen cup is the vessel a specimen arrives in. Clinics that monitor their own reprocessing pair the sterilization monitoring collection with the 24-hour biological indicator 50-pack. 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.
Sources
- 21 CFR 864.9225, cell-freezing apparatus and reagents for in vitro diagnostic use
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, medical devices
- Health Canada, medical devices
- Standards Council of Canada
- CSA Group
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- Clinical and Laboratory Standards Institute
- Public Health Ontario, infection prevention and control
- World Health Organization
- US CDC, laboratory quality
- CCOHS, OSH answers
A cryobank is audited on the record that follows the vial. The printable freezer and vial log is a blank sheet with columns for the run, the vial, the position, the reagent and the operator, so a stored sample can be reconciled with the freeze it came from.
The vial log generator on the same page sizes the sheet to the number of freezers and racks a laboratory runs, so a single-freezer lab and a multi-site bank print the form at the volumes they need.
Every laboratory and every apparatus differs. 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
- Cell and tissue culture flasks in Canada vs the US: which rules
- Multiwell cell culture plates in Canada vs the US
- Laboratory quality control materials in Canada vs the US: which class
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 practice belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is a cell-freezing apparatus in Canada?
It is part of an in vitro diagnostic device system. Where no earlier rule catches it, it reaches Class I through Rule 8 of Part 2 to Schedule 1, and Rule 7 draws it up with any higher-class IVD it is used with.
What class is the apparatus in the United States?
It is a named entry at 21 CFR 864.9225 in Class I, and the openFDA classification API lists it under product code KSP.
Do the two countries agree on the class?
Yes. The apparatus is Class I in the United States and Class I in Canada, reached by a named entry on one side and by Rule 8 on the other.
Why does the cooling rate matter so much?
A sample cooled too quickly forms ice inside the cells and ruptures them, so a rate that is off the maker's curve is a loss of the sample rather than a slower result.
Is the reagent part of the same device?
In the United States the entry names the apparatus and reagents together, and in Canada the reagent follows the same IVD path. Changing one without checking the other changes part of a system.
What does Rule 7 change for an IVD used with another IVD?
It provides that the class of both IVDDs is that of the IVDD in the higher class, so a low-class apparatus used with a higher-class IVD is drawn up with it.
What should a laboratory check on the vial?
That the vial is rated for the freezing step and can be traced to the run it was frozen in. A vial without that record breaks the link between the sample and the freeze.
0 comments