Quick facts
- A stereopsis test measures stereoacuity - the fineness of depth perception the two eyes produce together.
- In the United States it files under 21 CFR 886.1460, Stereopsis measuring instrument, at Class I (general controls), product code HLC.
- In Canada there is no separate entry; the device is a non-invasive device classified by Rule 7(1) of Schedule 1 at Class I.
- Rule 3(b) does not pull a test up or down: it applies to surgical or dental instruments, and a stereotest is neither.
- Contour, random-dot and vectographic formats all share one class in both countries - the class follows the intended use, not the printing method.
- Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-12.
A stereopsis test asks one question: how well do the two eyes work as a pair? The patient looks at a target that carries a slightly different image for each eye and reports what stands out of the page, and the result is recorded as stereoacuity in seconds of arc. Optometrists use it in a paediatric examination, before a binocular vision programme and after a head injury; it is also a screening tool when a driving or occupational standard depends on depth perception. In the United States the device has its own named regulation number at Class I; in Canada it reaches Class I through a general rule for non-invasive devices. This article sets out both routes, the formats that share the same class, and the records a practice keeps. The perforated exam table roll that covers the chair in the same testing room is part of the same clinic order.
What is an ophthalmic stereopsis test?
A stereopsis test presents the patient with a target built so that the left and the right eye each receive a slightly displaced image. Where the two images coincide the viewer sees depth; the smallest displacement still perceived is the stereoacuity. The instrument may be a hand-held card, a plate book worn behind polarising glasses, a vectographic viewer or a digital stereo display. What they share is the measurement: a threshold of binocular depth perception, reported in seconds of arc.
Two features vary between formats and neither changes the class. One is the way the two images are separated - by colour, by polarisation, by a lenticular screen or by time. The other is the working distance and target size, which set the test's sensitivity at near or distance. Class follows intended use, so a Titmus-style plate book, a TNO random-dot book, a Frisby plate and a digital stereotest all sit in the same class in both countries even though they are ordered, stored and documented in different ways.
Is a stereopsis test a Class I device in the United States?
Yes. 21 CFR 886.1460 is titled Stereopsis measuring instrument and the entry sits at Class I (general controls). The openFDA device classification API lists the product code as HLC, Instrument, Measuring, Stereopsis, under that regulation number. A Class I device of this kind reaches the market under general controls - establishment registration, labelling rules and good manufacturing practice - rather than a premarket review of the individual device.
The regulation is written around the measurement, not the packaging. Whether the practice buys a disposable plate book or a reusable instrument with a certificate of calibration, both are described by the same number. That matters to a purchaser because the class, not the format, decides what paperwork the device carries into the clinic.
| Item | Detail |
|---|---|
| US regulation | 21 CFR 886.1460 - Stereopsis measuring instrument |
| US class | Class I (general controls) |
| Product code | HLC (Instrument, Measuring, Stereopsis) |
| Route to market | Registration and listing; general controls |
| Applied part | No contact with the eye; the target is viewed at a distance |
How does Canada classify a stereopsis test?
Canada keeps no named entry for a stereopsis test. It applies the classification rules in Schedule 1 of the Medical Devices Regulations. The relevant rule is Rule 7(1): "Subject to subrule (2), all other non-invasive devices are classified as Class I." A stereotest is non-invasive - it does not penetrate the body and does not contact the surface of the eye - so it lands on the general Class I default.
The reader who skips to Rule 2 will guess wrong. Rule 2(1) lifts to Class II the invasive devices that "come into contact with the surface of the eye". A stereotest is not in that set: the patient looks through an aperture or wears a viewer, and no part of the device meets the globe. Rule 3(b) is the other near miss - it fixes all surgical or dental instruments at Class I, but a measuring instrument used for a vision assessment is not a surgical or dental instrument, so Rule 3 is not the reason the class is what it is. Rule 7(1) is.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 886.1460, Class I |
| Class | Class I (Rule 7(1)) | Class I (general controls) |
| Governing text | Schedule 1, Rule 7(1) | 21 CFR 886.1460 |
| Route to market | Establishment licence; no device licence for Class I | Registration and listing |
| Would Rule 2(1) apply? | No; the device does not contact the eye | Not applicable |
Which test formats share the same class?
The class follows the device, not the printing method. A contour plate book, a random-dot book, a vectographic viewer and a digital stereo display are all instruments used to measure stereoacuity, so they are described the same way in both countries. What changes between them is the way the two eye views are separated and the working distance - not the class.
| Format | Typical clinical use | Class, Canada | Class, US |
|---|---|---|---|
| Contour stereo plates | Quick near stereoacuity screen | I (Rule 7(1)) | I (886.1460) |
| Random-dot plates | Monocular cue removed | I (Rule 7(1)) | I (886.1460) |
| Vectographic viewer | Polarised near test | I (Rule 7(1)) | I (886.1460) |
| Digital stereo display | Distance stereoacuity | I (Rule 7(1)) | I (886.1460) |
The one detail worth carrying into a purchase order is the applied part. None of these formats touches the eye, which is why the Class I default holds. A practice that adds an instrument with a headrest or a chin rest is still buying a non-invasive device; the class does not move.
Does a Class I stereopsis test still carry obligations in Canada?
Yes. Class I is a low-risk class, not an unregulated one. A Class I device does not receive a device licence of its own, but the manufacturer still holds an establishment licence and keeps the records the Medical Devices Regulations require, including distribution records and complaint handling. A Class II or higher device needs a licence under section 32 supported by a CAN/CSA-ISO 13485 certificate, which is why the class boundary matters more to a supplier than to an optometrist.
For the practice the obligation is practical rather than regulatory. A reusable instrument has to be cleaned between patients, and the manufacturer's written processing information has to be followed - that is where ISO 17664 sits. A disposable plate book is used once and discarded. Both are Class I, but the record-keeping burden lands in different places, and the purchase decision should reflect that.
Which standards apply to a vision-testing instrument?
Two families matter. The first is the ophthalmic-instrument family: ISO 15004-1 sets the general requirements that ophthalmic instruments are built and labelled to, so a supplier can show that a device is described the way the eye-care sector expects. The second is the general medicines-device family - ISO 13485 for quality management and ISO 14971 for risk management - which applies to the manufacturer whatever the class.
Where a reusable viewer is reprocessed, ISO 17664 governs the information the manufacturer must supply about cleaning and disinfection. A stereopsis test is not a critical device and does not need sterilisation after routine use, but the cleaning instruction still has to come from the manufacturer and be followed. Practices that print their infection-control manual from a template should paste in the manufacturer's instruction rather than the template's default.
What should a practice record when it buys one?
The useful record is short. Keep the product name with the abbreviation the practice uses in notes, the format, the working distance, the age range the test is validated for, the cleaning instruction from the manufacturer, and the supply source. Add the class reference - 21 CFR 886.1460 in the United States, Rule 7(1) of Schedule 1 in Canada - so that a reviewer can see why the item needed nothing more than general controls.
That line is also what makes a restock decision auditable. A clinic that screens children and one that tests post-concussion adults buy the same class of device for different reasons, and writing the intended use on the order is what lets a later reader tell the two apart.
A testing room restocks consumables on a schedule, not one item at a time. 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 nitrile examination gloves, 4 mil sits in the same catalogue. Reselling? become a distributor.
Sources
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, overview of device regulation
- US FDA, medical device databases
- Health Canada, medical devices
- Health Canada, establishment licensing
- Canadian Association of Optometrists
- College of Optometrists of Ontario, standards of practice
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- ISO 17664:2017, processing of health care products — information to be provided
- ISO 11607-1:2019, packaging for terminally sterilized medical devices
- ISO 11135:2014, ethylene oxide sterilization of medical devices
- Public Health Ontario, infection prevention and control
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- CCOHS, OSH answers
Printable record sheet. Screening rooms and pre-op bays live or die on their paper trail, and an eye-care log is no different. Open the free sterilization log sheet library — the downloadable pack holds a steam-cycle log, a reprocessing-room checklist and an equipment-maintenance sheet. No account and no sign-up; print as many copies as your autoclave log needs.
Log generator. Because a vision-testing room logs equipment checks the same way an operatory logs a cycle. Run the sterilization log generator to build a dated, facility-labelled cycle sheet you can print or file straight into your quality manual.
Ask a compliance specialist. If your clinic tests children, drivers or post-injury patients and you are unsure what the purchase record should say. Send your question — you get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Ophthalmic refractometers in Canada vs the US: which class applies
- Diagnostic condensing lenses in Canada vs the US: which class applies
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 is a stereopsis test in one sentence?
It is a device that measures stereoacuity - how finely a patient perceives depth by comparing the image each eye receives - and reports the threshold in seconds of arc.
Is a stereopsis test Class I or Class II in the United States?
Class I. It is filed under 21 CFR 886.1460, Stereopsis measuring instrument, with product code HLC, and reaches the market under general controls.
How is a stereopsis test classified in Canada?
There is no named entry. It is a non-invasive device, so Rule 7(1) of Schedule 1 of the Medical Devices Regulations places it at Class I.
Why does Rule 2 not push the test to Class II?
Rule 2(1) covers invasive devices that contact the surface of the eye. A stereotest is viewed, not applied to the eye, so no part of it meets the globe and Rule 2 does not apply.
What else is this called?
Stereoacuity testing, depth perception testing, a Titmus or polarised fly test, a random-dot stereotest, a Frisby plate and a vectographic test are all names used for the same family of measurement.
Do I need a licence to import a Class I stereotest into Canada?
A Class I device needs no device licence of its own, but the manufacturer must hold an establishment licence and keep distribution and complaint records; the importer should be able to name the establishment licence holder.
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