N356022

N356022 December 12, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 3822.19.0030; 3822.19.0080; 9027.50.4015 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

(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.3