Quick facts
- An automated sedimentation rate device measures the erythrocyte sedimentation rate in whole blood without the reader timing a column by eye.
- In the United States it files under 21 CFR 864.5800, Automated sedimentation rate device, at Class I, product code GKB, exempt from premarket notification.
- In Canada it is an in vitro diagnostic device used in the monitoring of disease, so Rule 4 of Schedule 1, Part 2 sets Class II.
- The instrument is a different article from the ESR tube the blood is drawn or settled in; the tube is a consumable and the instrument is an analyzer, which is why each carries its own class reading.
- Rule 7 would apply only where the instrument is used with a separate assay; an analyser that reads a whole-blood column is reached directly by Rule 4.
- Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-14.
An automated sedimentation rate device measures automatically the erythrocyte sedimentation rate in whole blood. Because a raised sedimentation rate indicates tissue damage or inflammation, the measurement is used as a general marker and as a way to follow the course of a disease over time. The United States keeps the instrument at Class I as a general-purpose haematology article; Canada reads it as a diagnostic in vitro diagnostic device at Class II. This article sets out both routes and where the tube ends and the instrument begins, with the graduated specimen cups used at the same draw station.
What is an automated sedimentation rate device?
It is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. The classical method lets a column of anticoagulated blood stand and reads the fall of the red-cell column in millimetres after a set interval; an automated instrument replaces the eye and the clock with a reader that follows the same physical event, and reports the number in the units the laboratory method uses.
The measurement is deliberately non-specific. A rise in the sedimentation rate points to inflammation or tissue damage rather than to a particular condition, so the result is read alongside the rest of the picture and, in serial use, against the patient's own earlier values. That is why the record keeps the method, the interval and the instrument alongside the number itself.
What class is an automated sedimentation rate device in the United States?
It is a named entry at Class I. 21 CFR 864.5800 is titled Automated sedimentation rate device, and the identification reads: "An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease." The device 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 GKB against 864.5800. The Class I placement reflects the American reading of the article as a haematology instrument whose result is supportive rather than decisive.
| Item | Detail |
|---|---|
| US regulation | 21 CFR 864.5800 - Automated sedimentation rate device |
| US class | Class I (general controls) |
| Product code | GKB |
| Route to market | Exempt from premarket notification under subpart E of part 807, subject to the limits of section 864.9 |
| Stated function | To measure the erythrocyte sedimentation rate in whole blood automatically |
| Read alongside | The erythrocyte sedimentation rate tube or column the blood settles in |
How does Canada classify an automated sedimentation rate device?
Canada keeps no named entry for the instrument, and reads it as an in vitro diagnostic device under the Medical Devices Regulations: it is used in vitro on a blood specimen to give information about a pathological state. Its class therefore comes from Part 2 of Schedule 1, and 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 one of the listed Class III categories applies — cancer screening, genetic testing, fetal congenital-disorder screening, disease staging, and the categories tied to an erroneous result causing death or severe disability.
A sedimentation rate instrument monitors a general inflammatory state; it is neither a cancer screen nor a staging test, so it sits on the Class II default. Rule 7 is the near miss — an IVDD used with another IVDD takes the class of the higher-risk article — but an analyser that follows a whole-blood column is reached by Rule 4 directly, and Rule 8, the residual Class I rule, is displaced by Rule 4 in any case.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 864.5800 - Automated sedimentation rate device |
| Class | Class II (Rule 4, IVDD used in diagnosis or patient management) | Class I (general controls) |
| Governing text | Schedule 1, Part 2, Rule 4 | 21 CFR 864.5800 |
| Consumable versus instrument | ESR tube and analyzer are separate articles | Tube and instrument sit in separate entries |
| Route to market | Device licence (Class II) with quality-system evidence | Registration and listing |
Why is the same class question answered differently from a coagulation analyser?
Because the two instruments sit on different rules even though both are haematology analysers. A coagulation instrument determines the onset of clot formation for in vitro coagulation studies, and it is used with a reagent that carries the diagnostic claim, which is why its class tracks the assay through the analyzer rule. A sedimentation rate instrument follows a physical settling event in whole blood and reports a single general value, so it is reached by the diagnostic default rather than through a companion assay.
The instructive part for a buyer is that "haematology analyser" is not a class. Two instruments that sit on the same bench can carry different readings, because each is classified by what it does and what it is used with rather than by the room it stands in.
What should a laboratory check before ordering one?
Four checks. First, confirm the reporting units and the interval the instrument uses, because a laboratory that reports against a reference interval has to match the method to the interval. Second, confirm the maker's calibration and verification routine and how a result is traced to the instrument serial. Third, confirm the tube or consumable the instrument is designed to read, since the consumable and the instrument are separate articles with their own class readings. Fourth, confirm that the instrument's own documentation states the class it holds in each market, because the two answers differ.
A diagnostic laboratory also restocks the consumables used at the same draw and bench station. 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 affect the laboratory's quality routine?
The class sets the market-entry evidence the maker holds; it does not set the laboratory's routine. Under a medical-laboratory quality framework the laboratory verifies the instrument before reporting results from it, checks it against the reference interval or control material it uses, and keeps the record for as long as its document control requires.
That routine is the same whether the instrument is registered under general controls or carried under a device licence. What the Canadian Class II reading changes is what a laboratory can ask a supplier to produce — a device licence supported by quality-system evidence — and that becomes part of the supplier qualification rather than part of the bench procedure.
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 instrument-and-control sheet. A sedimentation result is only comparable with the patient's earlier values if the instrument serial, the interval and the control that was run beside it are written down, and all four fit on one page. The compliance log centre holds the blank sheet — print it from the browser, no account and no sign-up.
Fill the header once. Enter the laboratory name, the instrument serial and the method reference once, and the sterilization log generator lays out a dated page you can print or file into the quality manual.
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
- ESR tubes in Canada vs the US
- Coagulation analysers in Canada vs the US
- Blood cell counters 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 sedimentation rate device in the United States?
Class I under 21 CFR 864.5800, product code GKB, exempt from premarket notification subject to the limits of section 864.9.
What class is it in Canada?
Class II. It is an in vitro diagnostic device used in monitoring a disease, and Rule 4 of Part 2 of Schedule 1 sets that default at Class II.
Is the ESR tube the same device as the instrument?
No. The tube or column the blood settles in is a consumable article, while the analyser is an instrument that reads the settling automatically. Each carries its own class reading.
Do the two countries disagree on the class?
Yes. The United States places the instrument at Class I with an exemption; Canada reads the same instrument as a diagnostic IVDD and places it at Class II.
Does Rule 7 apply to the analyser?
Rule 7 applies where an IVDD is used with another IVDD and takes the higher class. An analyser that follows a whole-blood column is reached by Rule 4 directly, so Rule 7 is the near miss rather than the governing rule.
Does the class change the units the laboratory reports?
No. The reporting units and the reference interval come from the method the laboratory uses. The class sets the market-entry path for the instrument.
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