Smell Test Kit: Contents Checklist and FDA Classification

General product and regulatory information only, drawn from the U.S. Code of Federal Regulations and FDA’s device classification record. It is not medical advice and cannot tell anyone whether they have lost their sense of smell; that question belongs with a clinician.

A smell test kit is a set of odorants, presented to a person’s nose, that is used to check whether the sense of smell is working. In U.S. regulation the product is called an olfactory test device: Class II, with a named special-controls guidance, and in most cases exempt from 510(k) premarket notification. This page is for staff, students and buyers who need to know what such a kit typically contains, how FDA categorizes it, and what the regulation does and does not say.

Purpose and setting

What is a smell test kit? Under 21 CFR 874.1600, an olfactory test device is used to determine whether an olfactory loss is present. The regulation says the device includes one or more odorants that are presented to the patient’s nose to subjectively assess the patient’s ability to perceive odors (eCFR, checked 2026-10-31).

That definition is deliberately broad. It covers any format that presents odorants and asks the person to respond, so it does not by itself describe a booklet, a pen or a bottle. It is also different from the bench technique of wafting a chemical vapor toward the nose, which is a laboratory safety practice and not a test of a person’s sense of smell.

Checklist table: what a kit typically contains

FDA’s product classification record for code NRK is the primary description of kit contents (“Kit, Test, Olfactory”). That record describes one example, a home test for loss of the sense of smell, packaged in a small carton. The table lists it as an example described by FDA; other products may be built differently, and a manufacturer’s instructions for use list what its own kit contains.

Item	Quantity in FDA’s example	Role in the kit	Notes
Instruction book	1	Explains how the test is taken	Listed first in FDA’s description
Booklet of microencapsulated smell strips	1 booklet, twelve strips, each on a separate page	The odorants presented to the person	Microencapsulated strips, one per page
Scoring instructions	Included with the booklet	Tell the person scoring the test how to count responses	Described as part of the booklet
Answer key	Included with the booklet	Lists the expected answers	Described as part of the booklet
Physician information card	1	Information for the clinician who receives the result	Listed last in FDA’s description

The same record lists the device as Class 2, regulation number 874.1600, review panel Ear, Nose and Throat, and not exempt from good manufacturing practice requirements (openFDA device classification endpoint, checked 2026-10-31). Its associated submission number is DEN050007.

What varies by facility type

The regulation does not set different rules for clinics, hospitals, schools or homes. What changes the regulatory treatment is the indication, not the setting. According to 21 CFR 874.1600(b), the 510(k) exemption applies subject to the limitations in 21 CFR 874.9, and when the device is indicated for the screening or diagnosis of diseases or conditions other than the loss of olfactory function, it is not exempt from premarket notification.

• Intended use: the regulation exempts the device from 510(k) subject to 21 CFR 874.9, and states that a device indicated for screening or diagnosing conditions other than loss of olfactory function is not exempt. Section 874.9 also removes an exemption when a device is intended for a use different from legally marketed devices of its type, or uses a different fundamental technology.
• Format: the regulation says “one or more odorants”, so a kit may hold anything from a single odorant to a full booklet.
• Who uses it: FDA’s example is described as a home test with a card for the physician, which shows the same product can be taken outside a clinic and still be read by one.

Storage, expiry and restocking

Neither 21 CFR 874.1600 nor FDA’s classification record gives a storage temperature, shelf life or restocking quantity for olfactory test kits. Those details are set by each manufacturer in its labeling, so storage conditions, any expiry date and the number of kits to hold on hand should be taken from the instructions for use that ship with the product.

Standards or rules that apply

• 21 CFR 874.1600, Olfactory test device (eCFR, checked 2026-10-31; source note 71 FR 32835, June 7, 2006): identification, Class II classification and the exemption limits described above. The special control is FDA’s guidance document “Class II Special Controls Guidance Document: Olfactory Test Device.”
• FDA product code NRK (openFDA device classification record, last updated 2026-10-19; checked 2026-10-31): device name, Class 2, Ear, Nose and Throat panel.
• Background: the device class system comes from the Medical Device Amendments of 1976, and the agency is described at FDA (Food and Drug Administration). Problems with a marketed device fall under Medical Device Reporting (MDR).

FAQ

Is a smell test kit regulated by FDA?

Yes. Olfactory test devices are classified under 21 CFR 874.1600 as Class II (special controls), and FDA’s product code is NRK.

Does a smell test kit need a 510(k)?

Generally no. The regulation exempts the device from 510(k) premarket notification, subject to the limitations in 21 CFR 874.9. The exemption does not apply when the device is indicated for screening or diagnosis of conditions other than loss of olfactory function.

What is in a smell test kit?

It depends on the product. FDA’s example for code NRK contains an instruction book, a booklet of twelve microencapsulated smell strips with scoring instructions and an answer key, and a physician information card.

What does the test determine?

The regulation says it is used to determine whether an olfactory loss is present, by subjectively assessing the ability to perceive odors. It does not identify the cause of any loss.

Sources

• eCFR, 21 CFR 874.1600, Olfactory test device: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-B/section-874.1600. Date checked: 2026-10-31.
• FDA Product Classification, product code NRK, via the openFDA device classification endpoint at https://api.fda.gov/device/classification.json?search=product_code:NRK. Date checked: 2026-10-31.
• eCFR, 21 CFR 874.9, Limitations of exemptions from section 510(k): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-A/section-874.9. Date checked: 2026-10-31.