CLA-2-90:OT:RR:NC:N1:105
Neena Shenai
Wilmer Cutler Pickering Hale and Dorr LLP
2100 Pennsylvania Avenue NW
Washington, DC 20037
RE: The tariff classification of gluten detection capsules and detection systems from China
Dear Ms. Shenai:
In your letter dated November 13, 2025, on behalf of your client, NIMA Partners, Inc., you requested a tariff
classification ruling. The samples were received, examined, and disposed of.
The first item under consideration is described as the single-use Gluten Detection Capsule. Each Capsule
contains a lateral flow antibody test strip with two proprietary antibodies designed to detect gluten, a
proprietary extraction buffer, and spindle-shaped features. The cap of the Capsule has teeth-shaped features.
When the cap is screwed down, it helps to grind the food and release the extraction buffer. The Capsule must
be inserted into the Sensor to complete the gluten detection test. Each Capsule measures 2.5 × 0.8 × 0.6
inches and weighs 0.05 lbs.
The second item under consideration is the Gluten Detection Sensor, which is a compact, triangular
electronic device that contains internal mechanisms to mix the food sample with the extraction buffer and
then analyze the antibody test strip by using its optical system to detect a fluorescent signal produced when
the gluten binds with the antibodies. The Sensor evaluates this signal through proprietary algorithms and
displays results within approximately four minutes. Results may also be viewed through the NIMA Partners
mobile application. The Sensor includes an OLED display, printed circuit board assembly, optics assembly,
mixing motor, housing components, and associated mechanical hardware. It measures 3.5 x 0.8 x 3 inches
and weighs 0.16 lbs.
To conduct a test, the user inserts a food sample into the Capsule and secures the cap, initiating an initial
grinding step. When the Capsule is placed into the Sensor, the Sensor’s motor engages a magnetic clutch,
further mixing the sample with the extraction buffer. The extraction buffer breaks down the food and releases
gluten proteins into the solution. After mixing, a compliant mechanism in the Capsule opens the foil liner
within the Capsule, allowing the prepared solution to flow up the antibody strip through capillary action. If
gluten is present at or above 10 parts per million (ppm), the two proprietary antibodies and conjugation
chemistry then binds with gluten proteins, generating a fluorescent signal. The Sensor then displays a wheat
icon if there is gluten in the food sample. If gluten is absent or below this threshold, a smiley face appears,
indicating that no gluten is present in the food sample.
In your letter, you suggest the applicable subheading for the Gluten Detection Capsule to be 3822.19.0030,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Diagnostic or laboratory
reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not
put up in the form of kits, other than those of heading 3006; certified reference materials: Diagnostic or
laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing,
whether or not put up in the form of kits: Other: Containing antigens or antisera: Other.” However, the
complete ingredient breakdown was not provided. If the Gluten Detection Capsule contains antigens or
antisera but no methyl chloroform, it will be classified under subheading 3822.19.0030, HTSUS. If the
Gluten Detection Capsule contains neither antigens, antisera, nor methyl chloroform, it will be classified
under subheading 3822.19.0080, HTSUS. In both subheadings, the general rate of duty will be free.
The applicable subheading for the Gluten Detection Sensor will be 9027.50.4015, HTSUS, which provides
for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers,
spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking
viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or
checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories
thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other:
Electrical: Chemical analysis instruments and apparatus.” The general rate of duty will be free.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes
“any person suffering from a permanent or chronic physical or mental impairment which substantially limits
one or more major life activities, such as caring for oneself, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.60, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped.” Sigvaris, 899 F.3d at 1314.
The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be
“specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons
to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs
and Border Protection (CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present that create a
substantial probability of use by the chronically handicapped so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general public is
so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
Based on the information provided, it is the opinion of this office that the Gluten Detection Capsule and
Gluten Detection Sensor are not specifically designed for use by the handicapped for secondary classification
purposes. In our view, the subject Gluten Detection Capsule and Gluten Detection Sensor are utilized to test
the gluten content of food. This can be done for a myriad of different reasons and would not be limited solely
or even predominately to people with Celiac disease. Furthermore, having Celiac disease does not
automatically mean a person is handicapped. Eligibility depends on the severity of the condition and how it
directly impaired one’s physical ability to perform one or more of the major life activities, such as eating. No
evidence was provided to indicate that users of the products are physically unable to eat. Rather, their need is
to consume gluten-free foods. Therefore, the secondary classification 9817.00.96, HTSUS, will not apply.
The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided
for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying
duty rates are provided at https://hts.usitc.gov/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Jason Christie at [email protected].
Sincerely,
(for)
Deborah Marinucci
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division