Quick facts
- An automated cell-locating device finds and presents blood cells on a peripheral blood smear so that an operator can identify and classify each cell according to type.
- In the United States it files under 21 CFR 864.5260, Automated cell-locating device, at Class II (performance standards), product code JOY.
- The same regulation number also carries LNJ (Analyzer, chromosome, automated), so the entry covers the locating function wherever it is applied.
- Canada treats the instrument as an in vitro diagnostic device and reads the class from the claim. Used in diagnosis, Part 2 Rule 4 gives Class II; offered as a bare locating instrument that produces no diagnostic result, Part 2 Rule 8 gives Class I.
- Part 2 Rule 7 pairs the instrument with any IVDD it is used with, so a locator run with a Class III assay takes that class for the use.
- Entries, classes, product codes and rule text below were checked against the eCFR, the consolidated Regulations and the openFDA classification database on 2026-10-14.
A cell-locating device is the microscope stage that finds the cells for you. It scans a stained peripheral blood smear, locates the white cells, and presents each one to the operator so that the differential can be read cell by cell without a manual search. The instrument does not classify the cells; the technologist does. That division of labour is exactly what makes the class question interesting, because the United States names one class for the instrument while Canada asks what the instrument is claimed to do. This article sets out both routes and the record a morphology bench keeps, with the graduated specimen containers that carry the slides' parent sample.
What is an automated cell-locating device?
It is a device used to locate blood cells on a peripheral blood smear so that the operator can identify and classify each cell according to type. The instrument stage moves the slide, a camera or an optical detector finds candidate cells, and the software presents each one at a magnification and position where the technologist can read it. Some instruments count and pre-classify as well; others present only, and the reading stays entirely with the operator.
That is the difference between a locator and a counter. A counter produces a cell count from a suspended sample; a locator produces an ordered set of images or fields from a smear, and the classification comes from a person. A laboratory can run one, the other or both, and the two have different regulation numbers in the United States and different routes to a class in Canada.
Is an automated cell-locating device a Class II device in the United States?
Yes. 21 CFR 864.5260 is titled Automated cell-locating device and the identification reads: \"An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type.\" The entry sits at Class II (performance standards).
The openFDA device classification API lists product code JOY (Device, automated cell-locating) and LNJ (Analyzer, chromosome, automated) under the same regulation number. The pairing is instructive: the entry is written around locating a cell for an operator to read, and the same class covers the cytogenetics bench where the instrument finds metaphase spreads instead of white cells.
| Item | Detail |
|---|---|
| US regulation | 21 CFR 864.5260 - Automated cell-locating device |
| US class | Class II (performance standards) |
| Product codes | JOY (device, automated cell-locating), LNJ (analyzer, chromosome, automated) |
| Route to market | Premarket notification with the performance standard applied |
| What it does | Locates cells on a smear so an operator can identify and classify each cell |
| What it does not do | It does not classify the cell; the operator does |
How does Canada classify an automated cell-locating device?
Canada starts from the definition. An in vitro diagnostic device is a medical device intended to be used in vitro for the examination of specimens taken from the body, and a locator that examines a blood smear is such a device, so the rules in Part 2 of Schedule 1 of the Medical Devices Regulations apply rather than the Part 1 rules.
The rules then ask a sequence of questions, and the answers decide the class. Rules 1 to 3 do not reach the instrument: it detects no transmissible agent, and it neither manages nor diagnoses a patient by itself. Rule 4 reaches an IVDD that is not subject to rules 1 to 3 and that is intended to be used in diagnosis or patient management, and places it at Class II unless one of its listed categories applies — cancer screening, genetic testing, fetal screening, an erroneous diagnostic result that could cause death or severe disability, disease staging, or drug and substance monitoring where an error could create an imminent life-threatening situation. Rule 8 then closes the schedule: if rules 1 to 7 do not apply, all other IVDDs are classified as Class I.
Which of the two governs turns on the claim the maker makes, and that is the honest answer a buyer needs. An instrument sold as part of a diagnostic system, or accompanied by a claim that it produces information used in diagnosis, is read against Rule 4 and lands at Class II — the same class the United States gives the family. An instrument offered as a locator that presents cells for an operator to classify, with no diagnostic claim of its own, is not caught by Rule 4 and falls to Rule 8 at Class I. Rule 7 sits over both readings: where the IVDD, including its analyzers, reagents and software, is intended to be used with another IVDD, the class of both is that of the higher-risk IVDD.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 864.5260, Class II |
| Class | Class II (Rule 4) if used in diagnosis; Class I (Rule 8) if a bare locating instrument | Class II (performance standards) |
| Governing text | Schedule 1, Part 2, Rules 4, 7 and 8 | 21 CFR 864.5260 |
| If run with a higher-class IVDD | Both take the higher class (Rule 7) | Unchanged by the reagent |
| Route to market | Device licence (Class II) or Class I obligations | Premarket notification with the performance standard |
Why does the claim decide the class in Canada?
Because the Canadian rules are written around intended use rather than around a list of named instruments. Rule 4 speaks of an IVDD intended to be used in diagnosis or patient management; Rule 8 is the residual for everything the earlier rules do not catch. A buyer who reads only the instrument's physical description will not find the answer, because there is no answer at that level: the same optical stage can be a Class I instrument or a Class II device depending on the words the manufacturer puts around it.
| Question the rules ask | Which rule answers it | Effect on the class |
|---|---|---|
| Does it detect a transmissible agent? | Part 2 Rules 1 and 2 | Not this device; those rules do not apply |
| Is it used for patient management? | Part 2 Rule 3 | Not on its own; the operator classifies |
| Is it intended to be used in diagnosis? | Part 2 Rule 4 | Class II, unless a listed category applies |
| Is it paired with another IVDD? | Part 2 Rule 7 | Takes the class of the higher-risk IVDD |
| Is it none of the above? | Part 2 Rule 8 | Class I |
The practical lesson for a laboratory is short. Keep the instrument's intended-use statement with the instrument, and keep the menu or system the instrument is validated with, because in Canada the two documents together set the class. A laboratory that buys a locator and later adds a diagnostic software module has changed the article's regulatory position, even though nothing on the bench has moved.
What should a laboratory check before ordering one?
Four checks. First, confirm the intended-use statement, because it is the document that decides between Class I and Class II in Canada. Second, confirm what the software presents and what it decides: a module that pre-classifies cells is doing more than locating them, and the scope of the claim should match the scope of the validation. Third, confirm the slide preparation and staining the instrument is qualified for, since a locator is only as good as the smears it is fed and a change of stainer can invalidate the set-up. Fourth, confirm the control and verification routine the maker states, including the reference slides or the proficiency samples used to show the instrument still finds what it found last month.
A hematology or morphology bench also reorders the specimen-handling supplies that sit on the same bench. 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 containers sits in the same catalogue. Consumables for this line are listed under diagnostic laboratories. Reselling? become a distributor.
How does the class affect a morphology bench?
The class sets the market-entry path; the bench routine is set by the method. A differential is recorded with the sample identity, the stain and the slide, the instrument and software version, the cell count read and the operator's classification, and the repeat or the manual review that followed any result outside the laboratory's stated limits. Where the instrument presents cells, the record should also show how many cells were read and whether the reading was interrupted or edited.
Because the instrument reads a specimen that cannot be repeated, the routine also includes the storage of the slide and the time limits the laboratory applies between preparation and reading, and the verification of the locator against reference material. None of that changes with the class; it is the ordinary routine of a morphology bench, and the record is what shows the instrument was used as the maker intended.
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
- Clinical and Laboratory Standards Institute
- Public Health Ontario, infection prevention and control
- ISO 15189:2022, medical laboratories, requirements for quality and competence
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, application of risk management to medical devices
- ISO 17511:2020, metrological traceability of values assigned to calibrators
- World Health Organization
- Standards Council of Canada
- CSA Group
- CCOHS, OSH answers
- Health Canada, medical device licence application guidance
A morphology bench sheet you can print and clip to the rack. Slide number, stain, cells read, operator and the review decision belong on one page rather than in three places. Open the compliance log centre for the blank sheet — no account and no sign-up, and the bench can print as many copies as it reads slides.
Build the month of bench checks in one pass. Enter the laboratory name, the instrument and the check list once, and the sterilization log generator lays out dated lines 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
- Hemocytometers in Canada vs the US
- Flow cytometers in Canada vs the US
- Hematocrit tubes and readers 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 an automated cell-locating device in the United States?
Class II (performance standards), under 21 CFR 864.5260, with product code JOY for the cell-locating device and LNJ for an automated chromosome analyzer.
What class is it in Canada?
It depends on the claim. An instrument intended to be used in diagnosis is Class II under Part 2 Rule 4; an instrument offered as a bare locator that produces no diagnostic result is Class I under Part 2 Rule 8.
Why does the same instrument have two answers in Canada?
Because the rules classify by intended use rather than by a list of named instruments. Rule 4 reaches an IVDD used in diagnosis or patient management; Rule 8 is the residual for everything the earlier rules do not catch.
What does Rule 7 do to the class?
Where an IVDD, including its analyzers, reagents and software, is intended to be used with another IVDD, both take the class of the IVDD in the higher-risk class. A locator run with a Class III assay takes that class for the use.
Does the operator's classification change the device class?
No. The fact that a technologist classifies the cell is a reason the locating instrument may carry no diagnostic claim of its own, which is what can put it at Class I in Canada. It does not change the US entry.
What else is an automated cell-locating device called?
It is also written as digital morphology scanner, automated differential scanner, cell finder and smear imaging system; the US regulation describes the same article as a device used to locate blood cells on a peripheral blood smear.
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