Quick facts
- A parasite concentration device is a specimen-collection chamber used to concentrate parasites from a stool specimen and carry the concentrate to the laboratory.
- In the United States it files under 21 CFR 866.2900, Microbiological specimen collection and transport device, at Class I; the device used solely to collect and transport concentrated parasites is exempt from premarket notification. Product code LKS.
- In Canada it is an in vitro diagnostic device used in the diagnosis of a disease, so Rule 4 of Schedule 1, Part 2 sets Class II — a real class difference between the two countries.
- Rule 4 is displaced only by the Class III categories in that rule (cancer screening, genetic testing, congenital disorders and the rest), none of which a parasite concentration device falls into.
- Rule 8, the residual Class I default for IVDDs, does not apply here because Rule 4 reaches the device first.
- Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-14.
A parasite concentration device does the unglamorous half of an ova-and-parasite work-up: it takes the stool specimen into a chamber with a fixative or a concentration fluid, spins or settles the heavier elements, and carries the concentrated material to the laboratory so that a wet mount or a stained smear is worth reading. The United States classifies the chamber at Class I and exempts the parasite use from premarket notification; Canada reads it as a diagnostic device at Class II. This article sets out both routes, with the graduated specimen cups a laboratory keeps at the specimen bench.
What is a parasite concentration device?
It is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage after collection and during transport from the collecting area to the laboratory. In the parasite-work-up version, the chamber is built around a concentration step — a filter, a sedimentation cone or a flotation fluid — so that the laboratory receives material in which a small number of organisms are more likely to be found.
The device aids in the diagnosis of disease caused by pathogenic microorganisms, and that is the phrase that matters for classification. The chamber itself does not identify an organism; it raises the yield of the specimen so that the identification step has something to work with. The distinction between a device that aids diagnosis and a device that performs a test is one both jurisdictions draw, and they draw the line in different places.
What class is a parasite concentration device in the United States?
Its parent entry is 21 CFR 866.2900, Microbiological specimen collection and transport device, at Class I (general controls). The regulation then names the parasite use directly: the device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807, subject to the limits of that part.
The openFDA device classification API lists product code LKS for the parasite concentration device under 866.2900. Two features of the American treatment are worth noting: the class is Class I, and the parasite-specific form is given an exemption in addition to that class, which reflects how the entry treats collection and transport as the low-risk end of the laboratory chain.
| Item | Detail |
|---|---|
| US regulation | 21 CFR 866.2900 - Microbiological specimen collection and transport device |
| US class | Class I (general controls) |
| Product code | LKS (parasite concentration device) |
| Parasite-specific provision | Device used solely to collect and transport concentrated parasites is exempt from premarket notification |
| Stated function | To preserve the viability or integrity of microorganisms in a specimen during storage and transport |
| Aids | The diagnosis of disease caused by pathogenic microorganisms |
How does Canada classify a parasite concentration device?
Canada keeps no named entry for the chamber, and does not treat it as simple collection equipment. Under the Medical Devices Regulations, an in vitro diagnostic device is a device used in vitro on a specimen taken from the body for the purpose of providing information about a physiological or pathological state. A parasite concentration chamber is used exactly that way, so it is an IVDD and its class comes from Part 2 of Schedule 1.
The governing rule is Rule 4: "An IVDD that is not subject to rules 1 to 3 and that is intended to be used in diagnosis or patient management is classified as Class II", unless it falls into one of the listed Class III categories — screening for or diagnosis of cancer, genetic testing, screening for congenital disorders in the fetus, disease staging, and the categories keyed to an erroneous result causing death or severe disability. A parasite concentration device used in the routine work-up of a gastrointestinal complaint is none of those, so it sits on the Class II default rather than the Class I default that Rule 8 gives to IVDDs no other rule reaches.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 866.2900 - Microbiological specimen collection and transport device |
| Class | Class II (Rule 4, IVDD used in diagnosis) | Class I (general controls) |
| Governing text | Schedule 1, Part 2, Rule 4 | 21 CFR 866.2900 |
| Extra provision | None; Rule 4 is the default for diagnostic IVDDs | Parasite-only device exempt from premarket notification |
| Route to market | Device licence (Class II) with quality-system evidence | Registration and listing |
Why is a specimen chamber a diagnostic device in one system and collection kit in the other?
The two systems ask different first questions. The American entry is organised around what the article physically is — a specimen collecting chamber — and then carves out an exemption for the parasite form of it. The Canadian rules are organised around what the device is used for, and a chamber used to prepare a specimen for a diagnostic examination is an IVDD performing a diagnostic role.
That difference is not a drafting accident; it is the shape of the two schemes. One starts from the named article and adjusts the burden; the other starts from the intended use and derives the class. For a buyer the practical result is a genuine class difference: the same chamber carries a Class I entry in the United States and a Class II obligation in Canada.
What should a laboratory check before ordering one?
Four checks. First, confirm the concentration method the device supports — sedimentation, flotation or filtration — because the fixative or fluid that comes with the kit is part of the method and the laboratory's procedure has to match it. Second, confirm the transport and storage conditions the maker states, since the entry that gives the device its class is written around preserving the specimen. Third, confirm the labelling the laboratory needs to attach so the specimen can be traced from the collection area to the bench. Fourth, confirm the maker's record of the class it holds in each market, because the two answers differ and the paperwork a laboratory can ask to see differs with them.
A diagnostic laboratory also restocks the bench consumables used through the specimen-receiving area. Clinics that stock for a whole practice can order through the wholesale programme and request a bulk quote for a standing or annual order; the graduated specimen cups sits in the same catalogue. Consumables for this line are listed under diagnostic laboratories. Reselling? become a distributor.
How does the class change what a laboratory can ask a supplier for?
In the United States the article is a Class I device sold under general controls, with an exemption from premarket notification for the parasite-specific form; a laboratory verifying a new supplier expects establishment registration and listing and a specification the supplier stands behind. In Canada the article is a Class II IVDD, so the maker holds a device licence supported by quality-system evidence, and that licence is something a laboratory can ask to see before it puts the chamber into its procedure.
The class does not change the laboratory's side of the work. The laboratory still verifies the method, keeps the control results and traces the specimen. What it changes is the evidence the supplier is expected to hold, and therefore what a laboratory can reasonably ask for during a supplier qualification.
Sources
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, medical device databases
- US FDA, overview of device regulation
- Health Canada, medical devices
- Health Canada, establishment licensing
- Standards Council of Canada
- CSA Group
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, application of risk management to medical devices
- ISO 15189:2022, medical laboratories, requirements for quality and competence
- Clinical and Laboratory Standards Institute
- Public Health Ontario, infection prevention and control
- World Health Organization
- US CDC, laboratory quality
- CCOHS, OSH answers
- ISO 15189:2022, medical laboratories, requirements for quality and competence
A printable specimen-receiving sheet. A concentration kit only pays off if the chamber arrives with the specimen identity, the collection time and the fixative still attached to it, and that is one line per specimen. The compliance log centre carries a blank receiving sheet you can print and keep at the bench — no account and no sign-up.
Set the labels up once. Enter the laboratory name, the receiving bench and the specimen types once, and the sterilization log generator returns a dated sheet with the columns already placed, ready to print or file.
Ask a compliance specialist. A classification question usually turns on how the device is used, not only on its name. Ask a compliance specialist — you get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Sputum collection containers in Canada vs the US
- Specimen acceptance criteria in Canada vs the US
- Midstream urine collection in Canada vs the US
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 dental procurement professionals and is not legal advice; the class of a device and the records a practice keeps belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is a parasite concentration device in the United States?
Class I under 21 CFR 866.2900, product code LKS. The device used solely to collect and transport concentrated parasites is also exempt from premarket notification.
What class is it in Canada?
Class II. It is an in vitro diagnostic device used in diagnosis, and Rule 4 of Part 2 of Schedule 1 sets that default at Class II.
Do the two countries disagree?
Yes — this is a real class difference. The United States places the chamber at Class I; Canada reads the same chamber as a diagnostic IVDD and places it at Class II.
Would Rule 8 apply in Canada instead?
No. Rule 8 is the residual Class I rule for IVDDs that no other rule reaches, and Rule 4 reaches a device used in diagnosis first.
Does the class change the concentration method the laboratory may use?
No. The concentration method is set by the laboratory's own procedure and by the fixative or fluid the kit is built around. The class sets the market-entry path for the device.
What record belongs with the specimen?
The specimen identity, the collection date and time, the fixative used, the transport conditions and the receiving bench, so the concentrate can be traced back to the collection that produced it.
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